MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-04-13 for ARTIFICIAL URINARY SPHINCTER 720157-01 manufactured by American Medical Systems.
[5738388]
Artificial urinary sphincter removed from pt. The cuff was found to have holes in it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5042207 |
| MDR Report Key | 4724303 |
| Date Received | 2015-04-13 |
| Date of Report | 2015-04-13 |
| Date of Event | 2015-03-31 |
| Date Added to Maude | 2015-04-24 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTIFICIAL URINARY SPHINCTER |
| Generic Name | ARTIFICIAL URINARY SPHINCTER |
| Product Code | FAG |
| Date Received | 2015-04-13 |
| Model Number | 720157-01 |
| Catalog Number | 720157-01 |
| ID Number | 3.5 CM |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-04-13 |