MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-11-14 for VOCARE BLADDER SYSTEM 1904 NA manufactured by Neurocontrol Corp..
[266473]
This patient was implanted with the vocare bladder system in 2002. While still hospitalized during the patient's recovery from the implantation procedure, the patient experienced difficulty emptying using the vocare device and is believed to have a distended bladder. A foley catheter was inserted for 1 week prior to further attempt to use the device. While the patient was able to continue to use the device, the patient experiences high residual volumes. The patient has been advised by their clinician to temporarily discontinue use of the vocare and to use a urinary catheter to facilitate bladder recovery. A follow-up report will be submitted when the patient outcome is determined.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530440-2002-00013 |
| MDR Report Key | 427881 |
| Report Source | 05 |
| Date Received | 2002-11-14 |
| Date of Report | 2002-10-15 |
| Date of Event | 2002-08-21 |
| Date Mfgr Received | 2002-10-15 |
| Date Added to Maude | 2002-11-18 |
| 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 | MICHAEL SOUTHWORTH |
| Manufacturer Street | 8333 ROCKSIDE ROAD |
| Manufacturer City | VALLEY VIEW OH 44125 |
| Manufacturer Country | US |
| Manufacturer Postal | 44125 |
| Manufacturer Phone | 2169120101 |
| 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 | 2002-11-14 |
| Model Number | 1904 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 416892 |
| Manufacturer | NEUROCONTROL CORP. |
| Manufacturer Address | 8333 ROCKSIDE RD. VALLEY VIEW OH 441256104 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 | 1. Required No Informationntervention | 2002-11-14 |