MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1997-10-09 for PHYSICIAN'S KIT, 1200 manufactured by Uromed Corp..
[112634]
Sales rep reported that after a pt wore a reliance device at a physician's office for about an hour the device could not be found for removal. An xray was performed and no device was found.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1224675-1997-00046 |
| MDR Report Key | 125936 |
| Report Source | 07 |
| Date Received | 1997-10-09 |
| Date of Report | 1997-09-16 |
| Date of Event | 1997-09-04 |
| Date Mfgr Received | 1997-09-04 |
| Device Manufacturer Date | 1997-06-01 |
| 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 | PHYSICIAN'S KIT, 1200 |
| Generic Name | PHYSICIAN'S KIT |
| Product Code | MNG |
| Date Received | 1997-10-09 |
| Model Number | PHYSICIAN'S KIT |
| Catalog Number | 1200 |
| Lot Number | 0000001885 |
| 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 | 123274 |
| Manufacturer | UROMED CORP. |
| Manufacturer Address | 64 A ST. NEEDHAM MA 02194 US |
| Baseline Brand Name | PHYSICIAN'S KIT, 1200 |
| Baseline Generic Name | PHYSICIAN'S KIT |
| Baseline Model No | PHYSICIAN'S KIT |
| Baseline Catalog No | 1200 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-10-09 |