MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2004-11-04 for VOCARE BLADDER SYSTEM 1637-1 * manufactured by Finetech Medical Ltd..
[352972]
User is not getting proper voiding from their equipment. Initially this was thought to be an equipment failure. During discussion it was revealed that the user has gained 8 to 10 pounds recently, this would explain the lack of stimulation and the user was advised that the equipment would need adjusting to give proper stimulation. The user advised that their doctor was not comfortable with making the adjustments and it was decided to contact dr who is a specialist in vocare to help. During the time that it took to contact dr the user developed a uti which is being treated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617096-2004-00003 |
| MDR Report Key | 553732 |
| Report Source | 04 |
| Date Received | 2004-11-04 |
| Date of Report | 2004-11-04 |
| Date of Event | 2004-08-06 |
| Date Mfgr Received | 2004-08-19 |
| Date Added to Maude | 2004-11-09 |
| 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 | 2004-11-04 |
| 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 | 543365 |
| Manufacturer | FINETECH MEDICAL LTD. |
| Manufacturer Address | 13 TEWIN CT. WELWYN 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 | 2004-11-04 |