Attached - 2025 September MPP FDA Submitted MAUDE Events
MPP Event Counts:
Tactra - 9
Genesis - 5
Spectra - 1
Total - 15
Tactra:
Infection - 0
Erosion - 0
Fracture - 0
Deformity - 2
Genesis:
Infection + Erosion - 1
Fracture - 0
Deformity - 0
MAUDE - Manufacturer and User Facility Device Experience
The MAUDE database houses medical device reports submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.
2025 September MPP MAUDE Events
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lasthope2.0
- Posts: 93
- Joined: Sat Oct 11, 2025 1:23 pm
2025 September MPP MAUDE Events
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Lifelong ED. Pills for 15 yrs. 2024: Malleable via subcoronal and circumcision by one of the highest volume surgeons. Result: ED cured! Side Effects: Lymphedema, Length loss 0.4"; Girth loss 1"; Reduced Sensitivity.
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easymoney
- Posts: 901
- Joined: Tue May 09, 2023 10:28 am
- Location: West Coast Fl.
Re: 2025 September MPP MAUDE Events
Does Rigicon not submit their failures?
Rigicon since 6-2023 happy to share my experience and do show and tell
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lasthope2.0
- Posts: 93
- Joined: Sat Oct 11, 2025 1:23 pm
Re: 2025 September MPP MAUDE Events
easymoney wrote:Does Rigicon not submit their failures?
Not so much.
I've only seen one significant event for Rigi10 so far. This was submitted in July for urethral erosion.
Event Description (Rigi10 - Report Number MW5173423):
It was reported that patient had an explant of their rigicon device. This was due to urethral erosion.
https://www.accessdata.fda.gov/scripts/ ... uence_no=1
Lifelong ED. Pills for 15 yrs. 2024: Malleable via subcoronal and circumcision by one of the highest volume surgeons. Result: ED cured! Side Effects: Lymphedema, Length loss 0.4"; Girth loss 1"; Reduced Sensitivity.
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