MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-02-26 for VOCARE BLADDER SYSTEM 1904 NA manufactured by Neurocontrol Corp.
[17764224]
Pt was implanted with vocare bladder system but reported reduced function. Eval of the pt shows over-distended bladder volume 1200ml) which is reported due to infrequent use of the device. This pt has a c4 spinal cord injury and requires assistance to use this device and has had several episodes. Recovery is expected. This report is considered complete and no follow up is planned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530440-2003-00003 |
| MDR Report Key | 444495 |
| Report Source | 05 |
| Date Received | 2003-02-26 |
| Date of Report | 2003-01-27 |
| Date Mfgr Received | 2003-01-27 |
| Date Added to Maude | 2003-02-26 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | KATHIE MIZAK |
| Manufacturer Street | 8333 ROCKSIDE ROAD |
| Manufacturer City | VALLEY VIEW OH 44125 |
| Manufacturer Country | US |
| Manufacturer Postal | 44125 |
| Manufacturer Phone | * |
| 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 | SACRAL ANTERIOR ROOT STIMULATOR FOR BLADDER/BOWEL |
| Product Code | GZC |
| Date Received | 2003-02-26 |
| Model Number | 1904 |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| 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 | 433473 |
| Manufacturer | NEUROCONTROL CORP |
| Manufacturer Address | 8333 ROCKSIDE RD VALLEY VIEW OH 44125 US |
| Baseline Brand Name | VOCARE BLADDER SYSTEM |
| Baseline Generic Name | SACRAL ANTERIOR ROOT STIMULATOR FOR BLADDER/BOWEL |
| Baseline Model No | 1904 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-02-26 |