MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-03-03 for VOCARE BLADDER SYSTEM 1637-1 * manufactured by Finetech Medical.
[404750]
User called to say that her vocare had not worked for several years. This was discussed with dr. G creasey several years ago and the possible need for revision surgery was discussed. At that time the user was suffering from health problems and could not go ahead. Now the user is in good health again and would like to have the possible failure investiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617096-2006-00001 |
| MDR Report Key | 682455 |
| Report Source | 07 |
| Date Received | 2006-03-03 |
| Date of Report | 2006-02-24 |
| Date Mfgr Received | 2006-02-20 |
| Date Added to Maude | 2006-03-09 |
| 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 | BLADDER CONTROLLER |
| Product Code | GZC |
| Date Received | 2006-03-03 |
| Model Number | 1637-1 |
| 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 | 671723 |
| Manufacturer | FINETECH MEDICAL |
| Manufacturer Address | 13 TEWIN CT. WELYN GARDEN CITY HERTFORDSHIRE UK AL7 1AU |
| Baseline Brand Name | VOCARE BLADDER SYSTEM |
| Baseline Generic Name | BLADDER CONTROLLER |
| Baseline Model No | 1637-1 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-03-03 |