MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1997-12-02 for STARTER KIT, SIZE 5, 1215 manufactured by Uromed Corp..
[20156828]
Pt reported she had to go to the emergency room as she had urinary retention for two days. Pt had catheterization and started passing blood clots. Ultimate diagnosis from md was "cystitis"
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1224675-1997-00054 |
| MDR Report Key | 136305 |
| Report Source | 07 |
| Date Received | 1997-12-02 |
| Date of Report | 1997-11-25 |
| Date of Event | 1997-11-23 |
| Date Mfgr Received | 1997-11-24 |
| Device Manufacturer Date | 1997-05-01 |
| Date Added to Maude | 1997-12-09 |
| 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 5, 1215 |
| Generic Name | RELIANCE |
| Product Code | MNG |
| Date Received | 1997-12-02 |
| Model Number | SIZE 5 |
| Catalog Number | 1215 |
| Lot Number | 0000001849 |
| ID Number | * |
| Device Expiration Date | 1999-05-01 |
| 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 | 133161 |
| 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 5 |
| Baseline Catalog No | 1205 |
| 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 | 1997-12-02 |