MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-01-09 for LIFE-TECH RPC 9PU * manufactured by Life-tech, Inc..
[307238]
Rectal catheter from urodynamic study removed from rectum. Polyurethane balloon was no longer attached to the catheter. No attempt was made to remove the balloon due to pt anatomy at the time of the test. The balloon was passed rectally by the pt in a bowel movement. There was no adverse effect to the pt. Event was reported to the mfr by phone and letter 12/18/2002.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1027223 |
| MDR Report Key | 437617 |
| Date Received | 2003-01-09 |
| Date of Report | 2002-12-18 |
| Date of Event | 2002-12-13 |
| Date Added to Maude | 2003-01-16 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFE-TECH |
| Generic Name | ABDOMINAL PRESSURE CATHETER |
| Product Code | GBT |
| Date Received | 2003-01-09 |
| Model Number | RPC 9PU |
| Catalog Number | * |
| Lot Number | 4C27002 |
| ID Number | * |
| Device Expiration Date | 2005-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 426558 |
| Manufacturer | LIFE-TECH, INC. |
| Manufacturer Address | 4235 GREENBRIAR DR STAFFORD TX 77477 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-01-09 |