MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-11-06 for VOCARE BLADDER SYSTEM 1637-1 * manufactured by Finetech Medical.
[521830]
Ndi medical 01-november-2006: rec'd an email from dr. Stating that the user is scheduled to have the implantable receiver stimulator replaced. Dr. Was contacted to obtain add'l info. 3-november-2006: dr. States that implantable receiver is working intermittently.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617096-2006-00004 |
| MDR Report Key | 780446 |
| Report Source | 07 |
| Date Received | 2006-11-06 |
| Date of Report | 2006-11-06 |
| Date of Event | 2006-11-01 |
| Date Mfgr Received | 2006-11-03 |
| Date Added to Maude | 2006-11-15 |
| 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 CT. 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 | 2006-11-06 |
| Model Number | 1637-1 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 768224 |
| 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 | 2006-11-06 |