MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-01-21 for VOCARE BLADDER SYSTEM 1640 * manufactured by Finetech Medical Ltd..
[309816]
Vocare bladder system implantable components not functioning. Pt scheduled for surgery to evaluate and possibly replace implantable components. Physician will provide further info following surgery and will return device for eval if removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617096-2004-00001 |
| MDR Report Key | 513493 |
| Report Source | 05 |
| Date Received | 2004-01-21 |
| Date of Report | 2003-12-29 |
| Date of Event | 2003-01-01 |
| Date Mfgr Received | 2004-01-12 |
| Device Manufacturer Date | 1999-12-01 |
| Date Added to Maude | 2004-03-02 |
| 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 | FINETECH MEDICAL LTD |
| Manufacturer Street | 13 TEWIN COURT WELWYN GARDEN CITY |
| Manufacturer City | HERTFORDSHIRE AL71AU |
| Manufacturer Country | UK |
| Manufacturer Postal Code | AL7 1AU |
| 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 | 2004-01-21 |
| Model Number | 1640 |
| Catalog Number | * |
| Lot Number | 1105 |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 502502 |
| Manufacturer | FINETECH MEDICAL LTD. |
| Manufacturer Address | 13 TEWIN CT. WELWYN 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 | 2004-01-21 |