MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,04,07 report with the FDA on 1997-12-23 for US RELIANCE SIZE/PK UNK * manufactured by Uromed Corp..
[74648]
Pt reported not being able to find tab so she went to er and the device was removed and discarded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1224675-1997-00055 |
| MDR Report Key | 140045 |
| Report Source | 00,04,07 |
| Date Received | 1997-12-23 |
| Date of Report | 1997-12-23 |
| Date of Event | 1997-12-12 |
| Date Mfgr Received | 1997-12-19 |
| Date Added to Maude | 1997-12-30 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | US RELIANCE SIZE/PK UNK |
| Generic Name | RELIANCE |
| Product Code | MNG |
| Date Received | 1997-12-23 |
| Model Number | * |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 136726 |
| Manufacturer | UROMED CORP. |
| Manufacturer Address | 64 A ST. NEEDHAM MA 02194 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-12-23 |