MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-07-19 for SPECTRA 720054-01 manufactured by American Medical Systems, Inc..
[1366594]
A (b)(6) male who was obese had difficulty aiming urinary stream; desired a semi rigid implant. On (b)(6)2010, the patient was implanted with a spectra penile prosthesis. The distal tip of the prosthesis torn through glans after implant with maneuvering. Patient had significant corporal fibrosis which required additional effort to dilate. The penile prosthesis was removed, tear in glans were sutured, foley catheter remains in place. Patient was admitted for observation. Ams has requested additional information.
Patient Sequence No: 1, Text Type: D, B5
[8610722]
This is considered an unusual event in which an ams spectra device was involved. We have requested additional information from the doctor and currently waiting for his response. As soon as ams receives additional information, we will file a follow-up report. The device was returned for analysis and was rated within specification. No allegation of malfunction was indicated or related to this event. Analysis results: cylinder performed within specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183959-2010-00310 |
| MDR Report Key | 1768356 |
| Report Source | 05 |
| Date Received | 2010-07-19 |
| Date of Report | 2010-07-12 |
| Date of Event | 2010-07-12 |
| Date Mfgr Received | 2010-07-12 |
| Device Manufacturer Date | 2009-08-01 |
| Date Added to Maude | 2010-07-28 |
| 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 | CAROL SCHMOCK |
| Manufacturer Street | 10700 BREN ROAD WEST |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal | 55343 |
| Manufacturer Phone | 9529306425 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPECTRA |
| Generic Name | CONCEALABLE PENILE PROSTHESIS |
| Product Code | JCW |
| Date Received | 2010-07-19 |
| Returned To Mfg | 2010-07-15 |
| Model Number | 720054-01 |
| Catalog Number | 720054-01 |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 10700 BREN ROAD WEST MINNETONKA MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2010-07-19 |