MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2005-10-28 for VOCARE BLADDER SYSTEM 1637-1 * manufactured by Finetech Medical Ltd..
[433421]
Rec'd phone call from reporter/coordinator reporting that she was scheduling for annual f/u visit and learned that the user had died of urosepsis in 2005 due to refusing treatment. Coordinator will try to determine if the pt's device was functioning at the time. Coordinator states that with treatment the pt would have most likely recovered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617096-2005-00001 |
| MDR Report Key | 643698 |
| Report Source | 08 |
| Date Received | 2005-10-28 |
| Date of Report | 2005-10-24 |
| Date of Event | 2005-02-06 |
| Date Mfgr Received | 2005-10-21 |
| Date Added to Maude | 2005-11-01 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Remedial Action | OT |
| 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 | 2005-10-28 |
| 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 | 633205 |
| Manufacturer | FINETECH MEDICAL LTD. |
| Manufacturer Address | 13 TEWIN CT. HELWYN GARDEN CITY, HERTFORDSHIRE UK AL7 IAU |
| 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. Death | 2005-10-28 |