FDA Adverse Event
Injury
Summary report: N
PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN
MDR report key: 10327188
·
Received July 27, 2020
Report
- Report Number
- 3003477176-2020-00099
- Event Type
- Injury
- Date Received
- July 27, 2020
- Date of Event
- June 1, 2020
- Report Date
- January 8, 2021
- Manufacturer
- UROMEDICA, INC
- Product Code
- EZY
- PMA / PMN Number
- P130018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 0
BLADDER EROSION AND MIGRATION OF A PROACT IMPLANT. CONFIRMED BY CT IMAGING. PATIENT UNILATERALLY EXPLANTED. THE PATIENT REMAINED FULLY DRY (AND IS STILL DRY AS OF (B)(6) 2020 WITH THE ONE REMAINING BALLOON IN VIVO. AS A RESULT, THE PATIENT WAS NOT RE-IMPLANTED AND IS NOT CURRENTLY SCHEDULED FOR RE-IMPLANT.
Additional Manufacturer Narrative · 1
THIS SAME PATIENT EXPERIENCED A SECONDARY ADVERSE EVENT, A SKIN EROSION, IMMEDIATELY PRIOR TO THE (B)(6) 2020 EXPLANT. THAT ADVERSE EVENT WILL BE REPORTED SEPARATELY WITHIN REPORT 3003477176-2020-00102.
Description of Event or Problem · 1
BLADDER EROSION AND MIGRATION OF A PROACT IMPLANT. CONFIRMED BY CT IMAGING. PATIENT EXPLANTED, WILL BE RE-IMPLANTED AT A LATER DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 794267 | PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN | PROACT | EZY | UROMEDICA, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |