MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 1997-10-16 for US RELIANCE SIZE/PK UNK manufactured by Uromed Corp..
[71392]
Patient reported while she was removing the device, she remembers pulling the string and hearing the balloon deflate, but does not recall seeing or feeling the device come out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1224675-1997-00050 |
| MDR Report Key | 126901 |
| Report Source | 04,07 |
| Date Received | 1997-10-16 |
| Date of Report | 1997-10-15 |
| Date of Event | 1997-09-10 |
| Date Mfgr Received | 1997-10-10 |
| Date Added to Maude | 1997-10-21 |
| 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 | 1997-10-16 |
| Model Number | UNK |
| 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 | 124194 |
| Manufacturer | UROMED CORP. |
| Manufacturer Address | 64 A ST. NEEDHAM MA 02194 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-10-16 |