MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2004-07-20 for VOCARE BLADDER SYSTEM 1640 * manufactured by Finetech Medical Ltd..
[20990077]
Vocare bladder system implantable components no longer functioning. User reported problems started in 10/2002 after they suffered a seatbelt injury during a care accident. Then in 2003 when they were stretching contractures their leg something came loose. Ct scan showed fat lifted up from hip tissue and implant out of pocket. Pt suffering skin irritation around implant site with the implant being close to the skin surface and folding when they try to bend, also experiencing muscle spasm in legs and back. User will be evaluated when this can be arranged with their insurance but could take several mos.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617096-2004-00002 |
| MDR Report Key | 613937 |
| Report Source | 04 |
| Date Received | 2004-07-20 |
| Date of Event | 2003-01-01 |
| Date Mfgr Received | 2004-07-12 |
| Date Added to Maude | 2005-06-16 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | PETER FAIRHURST |
| Manufacturer Street | 13 TEWIN COURT WELWYN GARDEN CITY |
| Manufacturer City | HERTFORDSHIRE AL7 1AU |
| Manufacturer Country | UK |
| Manufacturer Postal | AL7 1AU |
| Manufacturer Phone | 707330942 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VOCARE BLADDER SYSTEM |
| Generic Name | ACTIVE IMPLANT - BLADDER CONTROLLER |
| Product Code | GZC |
| Date Received | 2004-07-20 |
| Model Number | 1640 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 603738 |
| Manufacturer | FINETECH MEDICAL LTD. |
| Manufacturer Address | 13 TEWIN CT. WELYN GARDEN CITY HERTFORDSHIRE UK AL7 1AU |
| Baseline Brand Name | VOCARE BLADDER STIMULATOR |
| Baseline Generic Name | ACTIVE IMPLANTABLE DEVICE - BLADDER CONTROLLER |
| Baseline Model No | 1640 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-07-20 |