PENUMA
Report
- Report Number
- MW5110082
- Event Type
- Injury
- Date Received
- June 2, 2022
- Date of Event
- September 27, 2019
- Report Date
- June 26, 2024
- Manufacturer
- INTERNATIONAL MEDICAL DEVICES, INC.
- Product Code
- MIB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
- Health Professional
- *
Narratives
ADDITIONAL INFORMATION RECEIVED FROM REPORTER ON 06/22/2022. THE MESH IS BARELY MENTIONED IN THE FDA FILINGS, AND PATIENTS ARE NOT INFORMED OF THIS PRIOR TO IMPLANT. THE HERNIA MESH IS USED IN CONJUNCTION WITH THE PENUMA, FOR SUTURING THE PENUMA TO THE TISSUE AND FASCIA WITHIN THE PENIS. THE PENUMA IMPLANT, IS A STATIC OBJECT IN A DYNAMIC ORGAN, FORCING THE PENIS TO NEVER BE FULLY-FLACCID OR ALLOWING FOR FULL EXPANSION DURING ERECTION. DURING THE TIME OF CONSULTATION, THE OFFICE STAFF AND DOCTOR RUSH EACH PATIENT THROUGH AND ONLY PROVIDE THE SURGICAL CONSENT FOR AFTER EACH PATIENT PAYS A NON-REFUNDABLE DEPOSIT-ENTRAPPING EACH PATIENT INTO A LOSS WITH EITHER CHOICE.
ADDITIONAL INFORMATION RECEIVED FROM REPORTER FOR MW5110082. IT WAS ALSO CLAIMED THAT THE INVENTOR OF THE PENUMA, WAS A BOARD CERTIFIED UROLOGIST. I HAVE SEARCHED FOR HIS NAME ON ONLINE MEDICAL SPECIALIST DATABASES AND NEVER FOUND HIS NAME. BESIDES PERMANENTLY ADVERSELY AFFECTING THE NERVES AND BLOOD VESSELS OF THE PENIS, THE PENUMA IMPLANT FOSTERS PERMANENT DISFIGUREMENT BOTH DURING AND AFTER ITS REMOVAL. THESE ARE JUST A SMALL LIST OF THINGS THAT WERE NEVER SHARED WITH ME PRIOR TO SURGERY. IF ANY OF THE CLAIMS WERE TRUTHFUL, IT WOULD NOT CAUSE THIS LEVEL OF DAMAGE TO ME, AS WELL AS COUNTLESS OTHERS. AFTER 8-10 WEEKS, THE DR. (B)(6) NOR THE MANUFACTURER DOES NOTHING TO FOLLOW UP OR TRACK ANY ISSUES. ANY ISSUES THAT ARE BROUGHT UP WITHIN THAT TIMEFRAME ARE DISMISSED AND DISCOUNTED. THERE IS NO TRACKING OF ANY ISSUES, NOR DOES DR. (B)(46 OR THE MANUFACTURER OF PENUMA RECORD OR RELAY ANY ISSUES, NOR DO THEY PROVIDE ANY ISSUE TRACKER OR PATHWAY TO RELAY ISSUES TO THE FDA, OTHER THAN WHEN A PATIENT TAKES IT UPON THEMSELVES TO VOLUNTARILY SEARCH AND RELAY ISSUES ABOUT THE PENUMA SUCH AS THIS. I CONTINUALLY STATED MY CONCERNS TO DR. (B)(6) ASSISTANTS AND OFFICE REGARDING THE SEVERE DISCOMFORT AND FAILURES OF THE CLAIMS OF DR. (B)(6) AND MANUFACTURER THAT IT WOULD FEEL NATURAL. THE DEVICE NEVER FELT OR LOOKED NATURAL. THE MORE ERECTIONS I HAD THROUGHOUT EACH CONTINUING DAY SHOWED THE FAULTS OF THE IMPLANT AND THE LACK OF VERACITY BEHIND THE MANUFACTURER'S AND DR. (B)(6) CLAIMS. THE PENUMA DEVICE CAUSES SEVERE PAIN AND PROTRUDED FROM UNDER THE SKIN, RISKING THAT THE PENUMA WOULD WEAR THROUGH THE SKIN AND CAUSE UNTOLD TRAUMA. DR. (B)(6) ASSISTANTS, OFFICE, AND DR. (B)(6) ALL DISMISSED AND DISCOUNTED MY CONCERNS. THE PENUMA IMPLANT IS PERMANENTLY DISFIGURING, PERMANENTLY DAMAGING, FOMENTS UNFORESEEN OR UNSHARED ISSUES FOR EACH PATIENT, AND WILL ULTIMATELY FAIL IN ALMOST EVERY PATIENT, IF ENOUGH TIME PASSES. GIVEN ALL OF THIS, THE PENUMA SHOULD ABSOLUTELY NOT BE AVAILABLE FOR THE GENERAL POPULATION. THIS DEVICE HAS CAUSED PERMANENT, IRREPARABLE DAMAGE TO ME, DESPITE THEIR MARKETING CLAIMS THAT IT IS COMPLETELY REVERSIBLE. ANY AND ALL COMPLAINTS TO DR. (B)(6), MEDICAL STAFF, WERE NEVER NOTED, MARKED DOWN, RELAYED OR TRANSMITTED TO THE FDA, OR MET WITH ANY SOLUTION OR CARE. (B)(4).
I HAD THE PENUMA IMPLANT FROM DR. (B)(6) IN (B)(6) 2019. I HAD A SLIGHT PENILE CURVATURE AND WAS TOLD AT THE TIME OF THE SURGICAL CONSULTATION THAT I HAD PEYRONIES'. I ALSO FILLED OUT THEIR QUESTIONNAIRES REGARDING MY SELF-ESTEEM, AND SELF-VIEW, AND RESPONDED THAT I FELT CONFIDENT IN MY SEX LIFE AND SELF-VIEW, BUT JUST SIMPLY WANTED TO IMPROVE THE SLIGHT PENILE CURVATURE. IT WAS CLAIMED PRIOR TO THE TIME OF THE SURGICAL CONSULTATION THAT THE PENUMA WAS "THE FIRST FDACLEARED PENILE IMPLANT FOR COSMETIC ENHANCEMENT." IT WAS ALSO CLAIMED THAT THE PENUMA IMPLANT WAS COMPLETELY REVERSIBLE. IT WAS ALSO CLAIMED THAT DR. (B)(6) WAS A BOARD CERTIFIED UROLOGIST. I LEARNED AFTER THE IMPLANT SURGERY THAT DR. (B)(6)PLACES DACRON MESH AROUND THE PENUMA AT THE TIME OF SURGERY, TO ENCOURAGE THE FORMATION OF A FIBROUS SCAR TISSUE AROUND THE IMPLANT. POST SURGERY, I WAS INSTRUCTED TO CONTACT THE OFFICE FOR 8-10 WEEKS. I INFORMED THEM PRIOR TO THE POST-SURGICAL VISITS THAT I WOULD NEED TO CHECK-IN VIA PHONE CALLS FOR A PERIOD OF TIME, DUE TO INTERNATIONAL TRAVEL. PRIOR TO TRAVEL, I INFORMED THEM I HAD DEVELOPED A SEROMA. I CONTINUED FOLLOWING THEIR POST-SURGICAL PROTOCOL AS WELL AS CONTACTING THE SURGEON'S MEDICAL ASSISTANTS, WHO STATED THAT I SHOULD CONTINUE FOLLOWING PROTOCOL AND WAIT FOR THE SEROMA TO HEAL ON ITS OWN. BASED ON THE NATURAL INFLATION AND DEFLATION OF BLOOD IN THE PENIS, THE SUTURES FOR THE PENUMA IMPLANT ALSO BEGAN TO UNTETHER, CAUSING THE PENUMA TO PROTRUDE AND FLARE OUT ON THE SIDES BEHIND THE GLANS. THE MEDICAL ASSISTANT CLAIMED THAT THEY WERE WAITING FOR THE 'CAPSULE' TO FORM AROUND THE PENUMA. THE SEROMA GREW TO 90- 120CC'S IN VOLUME. I CONTINUED TO STATE MY CONCERN REGARDING THE PROTRUSION OF THE IMPLANT FROM UNDER THE SKIN AS WELL AS THE LACK OF DECREASE IN THE SEROMA. I STATED THAT THE SKIN AROUND THE PENIS WAS BECOMING UNSTABLE AND DEVITALIZED FROM THE CONTINUED SEROMA, AND THAT IT WAS IMPERATIVE I HAVE A HEALTHCARE PROVIDER ASPIRATE THE SEROMA. THE MEDICAL ASSISTANT STATED THAT IF NEEDED, I SHOULD ASPIRATE THE SEROMA, BUT TO BE CAREFUL TO NOT DAMAGE THE IMPLANT. THE SEROMA WAS DRAINED TWICE, WITHOUT INCIDENT, AND I SUBSEQUENTLY REQUESTED AND SCHEDULED A DATE FOR THE PENUMA IMPLANT TO BE REMOVED IN (B)(6) 2020. I WAS EXAMINED BY DR. (B)(6), WHO THEN ALSO ASPIRATED THE SEROMA THE FINAL TIME. I WAS TOLD BY DR. ELIST THAT I 'WAS TOO BIG FOR THAT IMPLANT AND THAT I SHOULD 'UPGRADE' AT NO COST'. I REFUSED THE OFFER FOR THE 'UPGRADE' AND HAD THE IMPLANT REMOVED. I WASN'T PRESCRIBED ANY KENALOG OR ANYTHING TO MITIGATE THE FORMATION OR TREATMENT OF SCAR TISSUE, OTHER THAN A BILL FOR REMOVAL. I RECEIVED NO FOLLOW UP FROM THE IMPLANT REMOVAL, AND THERE ARE NO PLACES FOR ANY PATIENTS TO FILE ANY TRACKED COMPLAINTS OR ISSUES REGARDING THE PENUMA ON DR. (B)(6) WEBSITE. I BELIEVE ALL ISSUES CONVEYED TO DR. (B)(6) OFFICE ARE NOT SHARED WITH THE FDA REGARDING THE PENUMA. AFTER THE REMOVAL OF THE PENUMA IMPLANT, I NOTICED THAT MY PENIS STARTED TO RETRACT AND CONTRACT AS WELL AS CURVE UPWARDS. I'VE LATER LEARNED THAT THE SCAR TISSUE FORMED AROUND THE PENUMA, WHICH ELIST CALLS THE 'CAPSULE', RESULTS IN SCAR TISSUE FORMATION INSIDE THE PENIS, CAUSES CAPSULAR CONTRACTION, AND TRIGGERS LOSS OF LENGTH AND SENSATION IN PATIENTS. THE PENUMA IMPLANT SHOULD NEVER HAVE BEEN CLEARED FOR PLACEMENT INSIDE THE PENIS. THE INVENTOR MAKES WILDLY MISLEADING CLAIMS, AND THE RESULTS OF HAVING A PENUMA IMPLANT ARE IMPOSSIBLE TO HAVE REVERSED. THE FUNDAMENTAL DESIGN OF THE PENUMA IMPLANT, COUPLED WITH THE ACT OF IMPLANTATION, CAUSES PERMANENT SCARRING, DISFIGUREMENT, AND DAMAGE. IT HAS TAKEN YEARS AND MULTIPLE RECONSTRUCTIVE SURGERIES TO RETURN TO SOME SEMBLANCE OF NORMAL. I AM JUST ONE OF COUNTLESS OTHERS. WE HAVE NO WAY BACK TO NORMAL. GIVEN ENOUGH TIME, ALMOST ALL PATIENTS WILL HAVE SIMILAR NEGATIVE RESULTS. THE DESIGN AND USE OF THE PENUMA CAUSES IRREPARABLE HARM AND IS MENTALLY DEVASTATING TO PATIENTS. FDA SAFETY REPORT ID# (B)(4).
ADDITIONAL INFORMATION RECEIVED ON 26-JUN-2024, FOR MW5110082. CORRECTING PROCODE INFORMATION. REF REPORT: MW5156669.
I HAD THE PENUMA IMPLANT FROM DR. (B)(6) IN (B)(6) 2019. I HAD A SLIGHT PENILE CURVATURE AND WAS TOLD AT THE TIME OF THE SURGICAL CONSULTATION THAT I HAD PEYRONIES'. I ALSO FILLED OUT THEIR QUESTIONNAIRES REGARDING MY SELF-ESTEEM, AND SELF-VIEW, AND RESPONDED THAT I FELT CONFIDENT IN MY SEX LIFE AND SELF-VIEW, BUT JUST SIMPLY WANTED TO IMPROVE THE SLIGHT PENILE CURVATURE. IT WAS CLAIMED PRIOR TO THE TIME OF THE SURGICAL CONSULTATION THAT THE PENUMA WAS "THE FIRST FDACLEARED PENILE IMPLANT FOR COSMETIC ENHANCEMENT." IT WAS ALSO CLAIMED THAT THE PENUMA IMPLANT WAS COMPLETELY REVERSIBLE. IT WAS ALSO CLAIMED THAT DR. (B)(6) WAS A BOARD CERTIFIED UROLOGIST. I LEARNED AFTER THE IMPLANT SURGERY THAT DR. (B)(6)PLACES DACRON MESH AROUND THE PENUMA AT THE TIME OF SURGERY, TO ENCOURAGE THE FORMATION OF A FIBROUS SCAR TISSUE AROUND THE IMPLANT. POST SURGERY, I WAS INSTRUCTED TO CONTACT THE OFFICE FOR 8-10 WEEKS. I INFORMED THEM PRIOR TO THE POST-SURGICAL VISITS THAT I WOULD NEED TO CHECK-IN VIA PHONE CALLS FOR A PERIOD OF TIME, DUE TO INTERNATIONAL TRAVEL. PRIOR TO TRAVEL, I INFORMED THEM I HAD DEVELOPED A SEROMA. I CONTINUED FOLLOWING THEIR POST-SURGICAL PROTOCOL AS WELL AS CONTACTING THE SURGEON'S MEDICAL ASSISTANTS, WHO STATED THAT I SHOULD CONTINUE FOLLOWING PROTOCOL AND WAIT FOR THE SEROMA TO HEAL ON ITS OWN. BASED ON THE NATURAL INFLATION AND DEFLATION OF BLOOD IN THE PENIS, THE SUTURES FOR THE PENUMA IMPLANT ALSO BEGAN TO UNTETHER, CAUSING THE PENUMA TO PROTRUDE AND FLARE OUT ON THE SIDES BEHIND THE GLANS. THE MEDICAL ASSISTANT CLAIMED THAT THEY WERE WAITING FOR THE 'CAPSULE' TO FORM AROUND THE PENUMA. THE SEROMA GREW TO 90- 120CC'S IN VOLUME. I CONTINUED TO STATE MY CONCERN REGARDING THE PROTRUSION OF THE IMPLANT FROM UNDER THE SKIN AS WELL AS THE LACK OF DECREASE IN THE SEROMA. I STATED THAT THE SKIN AROUND THE PENIS WAS BECOMING UNSTABLE AND DEVITALIZED FROM THE CONTINUED SEROMA, AND THAT IT WAS IMPERATIVE I HAVE A HEALTHCARE PROVIDER ASPIRATE THE SEROMA. THE MEDICAL ASSISTANT STATED THAT IF NEEDED, I SHOULD ASPIRATE THE SEROMA, BUT TO BE CAREFUL TO NOT DAMAGE THE IMPLANT. THE SEROMA WAS DRAINED TWICE, WITHOUT INCIDENT, AND I SUBSEQUENTLY REQUESTED AND SCHEDULED A DATE FOR THE PENUMA IMPLANT TO BE REMOVED IN (B)(6) 2020. I WAS EXAMINED BY DR. (B)(6), WHO THEN ALSO ASPIRATED THE SEROMA THE FINAL TIME. I WAS TOLD BY DR. ELIST THAT I 'WAS TOO BIG FOR THAT IMPLANT AND THAT I SHOULD 'UPGRADE' AT NO COST'. I REFUSED THE OFFER FOR THE 'UPGRADE' AND HAD THE IMPLANT REMOVED. I WASN'T PRESCRIBED ANY KENALOG OR ANYTHING TO MITIGATE THE FORMATION OR TREATMENT OF SCAR TISSUE, OTHER THAN A BILL FOR REMOVAL. I RECEIVED NO FOLLOW UP FROM THE IMPLANT REMOVAL, AND THERE ARE NO PLACES FOR ANY PATIENTS TO FILE ANY TRACKED COMPLAINTS OR ISSUES REGARDING THE PENUMA ON DR. (B)(6) WEBSITE. I BELIEVE ALL ISSUES CONVEYED TO DR. (B)(6) OFFICE ARE NOT SHARED WITH THE FDA REGARDING THE PENUMA. AFTER THE REMOVAL OF THE PENUMA IMPLANT, I NOTICED THAT MY PENIS STARTED TO RETRACT AND CONTRACT AS WELL AS CURVE UPWARDS. I'VE LATER LEARNED THAT THE SCAR TISSUE FORMED AROUND THE PENUMA, WHICH ELIST CALLS THE 'CAPSULE', RESULTS IN SCAR TISSUE FORMATION INSIDE THE PENIS, CAUSES CAPSULAR CONTRACTION, AND TRIGGERS LOSS OF LENGTH AND SENSATION IN PATIENTS. THE PENUMA IMPLANT SHOULD NEVER HAVE BEEN CLEARED FOR PLACEMENT INSIDE THE PENIS. THE INVENTOR MAKES WILDLY MISLEADING CLAIMS, AND THE RESULTS OF HAVING A PENUMA IMPLANT ARE IMPOSSIBLE TO HAVE REVERSED. THE FUNDAMENTAL DESIGN OF THE PENUMA IMPLANT, COUPLED WITH THE ACT OF IMPLANTATION, CAUSES PERMANENT SCARRING, DISFIGUREMENT, AND DAMAGE. IT HAS TAKEN YEARS AND MULTIPLE RECONSTRUCTIVE SURGERIES TO RETURN TO SOME SEMBLANCE OF NORMAL. I AM JUST ONE OF COUNTLESS OTHERS. WE HAVE NO WAY BACK TO NORMAL. GIVEN ENOUGH TIME, ALMOST ALL PATIENTS WILL HAVE SIMILAR NEGATIVE RESULTS. THE DESIGN AND USE OF THE PENUMA CAUSES IRREPARABLE HARM AND IS MENTALLY DEVASTATING TO PATIENTS. FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2161551 | PENUMA | ELASTOMER, SILICONE BLOCK | MIB | INTERNATIONAL MEDICAL DEVICES, INC. | |||
| 2442268 | MESH | MESH, SURGICAL, POLYMERIC | MIB | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Male | Life Threatening| L| S| H| R| S| H| R | |
| 1 | 42 YR | Male | Life Threatening| L| S| H| R| S| H| R |