MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02,05 report with the FDA on 2012-03-22 for INFLATABLE PENILE PROSTHESIS manufactured by American Medical Systems, Inc..
[2594731]
On (b)(6) 2012, the pt underwent a replacement of his inflatable penile prosthesis (ipp). On (b)(6) 2012, the pt presented with a "superficial perineal wound infection with surrounding cellulitis" the infection occurred "due to the pt's poor hygiene. " on (b)(6) 2012, blood work was completed in the physician's office. On (b)(6) 2012, the pt was hospitalized and treated with linezolid for 4 days and discharged on (b)(6) 2012. On (b)(6) 2012, the pt was readmitted to hosp. The pt presented with "erythema, skin dehiscence, allergic reaction to the sulfa drug. " the pt was treated with benadryl for the allergic reaction to meds, switched to vancomycin iv for 24 hrs. " the pt was discharged from hosp on (b)(6) 2012.
Patient Sequence No: 1, Text Type: D, B5
[9844985]
(b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183959-2012-00320 |
| MDR Report Key | 2504695 |
| Report Source | 02,05 |
| Date Received | 2012-03-22 |
| Date of Report | 2012-02-22 |
| Date of Event | 2012-02-22 |
| Date Mfgr Received | 2012-02-22 |
| Date Added to Maude | 2012-03-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JON CORNELL, SR, MGR |
| Manufacturer Street | 10700 BREN RD., WEST |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal | 55343 |
| Manufacturer Phone | 9529306670 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INFLATABLE PENILE PROSTHESIS |
| Generic Name | IPP |
| Product Code | JCW |
| Date Received | 2012-03-22 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 10700 BREN RD., WEST MINNETONKA MN 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Other | 2012-03-22 |