MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 1997-10-09 for STARTER KIT, SIZE 4, 1214 manufactured by Uromed Corp..
[91565]
Pt reported she could not see or feel the device so she went to the hospital and had a manual exam and xrays. No device was found.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1224675-1997-00048 |
| MDR Report Key | 125730 |
| Report Source | 04,07 |
| Date Received | 1997-10-09 |
| Date of Report | 1997-09-19 |
| Date of Event | 1997-09-15 |
| Date Mfgr Received | 1997-09-17 |
| Device Manufacturer Date | 1996-10-01 |
| Date Added to Maude | 1997-10-15 |
| 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 | STARTER KIT, SIZE 4, 1214 |
| Generic Name | RELIANCE |
| Product Code | MNG |
| Date Received | 1997-10-09 |
| Model Number | SIZE 4 |
| Catalog Number | 1214 |
| Lot Number | 0000000009 |
| ID Number | * |
| Device Expiration Date | 1998-10-01 |
| 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 | 123077 |
| Manufacturer | UROMED CORP. |
| Manufacturer Address | 64 A ST. NEEDHAM MA 02194 US |
| Baseline Brand Name | RELIANCE |
| Baseline Generic Name | URETHRAL OCCLUSION DEVICE |
| Baseline Model No | SIZE 4 |
| Baseline Catalog No | 1204 |
| Baseline ID | * |
| Baseline Device Family | URINARY CONTROL INSERT |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | Y |
| Premarket Approval | P9600 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-10-09 |