MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-19 for CONCEAL 720185-01 manufactured by American Medical Systems, Inc..
[179945759]
Patient underwent implanted penile prosthesis placement. He experienced cellulitis within 15 days and was hospitalized for iv antibiotic therapy. The next month, the ipp was explanted and a new device placed. A pinpoint hole was found along his original incision during this procedure. No purulent drainage was found, so the wound was thoroughly washed out and a new ipp placed. One month later, the patient had to return to surgery for continued infective state and the ipp was removed. Again, no purulent drainage was found but the pinpoint hole in the incision line was still present. The ipp was removed and wash out was done again. A 3rd ipp was placed. He was sent home on antibiotics after each intervention. Patient has not returned to facility since this time. Tissue glue was used all three times to close the skin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9726846 |
| MDR Report Key | 9726846 |
| Date Received | 2020-02-19 |
| Date of Report | 2020-01-16 |
| Date of Event | 2019-12-11 |
| Report Date | 2020-01-16 |
| Date Reported to FDA | 2020-01-16 |
| Date Reported to Mfgr | 2020-02-19 |
| Date Added to Maude | 2020-02-19 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONCEAL |
| Generic Name | PROSTHESIS, PENIS, INFLATABLE |
| Product Code | JCW |
| Date Received | 2020-02-19 |
| Model Number | 720185-01 |
| Lot Number | 1000320682 |
| Device Availability | N |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 10700 BREN ROAD WEST MINNETONKA MN 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-19 |