MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-01-12 for MEDI-TECH 548818-01 22-530 manufactured by Medi-tech.
[1715]
Positioning stent and string broke, unable to position stent - replace laterdevice labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: mechanical problem. Conclusion: device failure occurred and was related to event, other. Certainty of device as cause of or contributor to event: yes. Corrective actions: other. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2293 |
| MDR Report Key | 2293 |
| Date Received | 1993-01-12 |
| Date of Report | 1992-12-04 |
| Date of Event | 1992-11-24 |
| Date Facility Aware | 1992-11-30 |
| Report Date | 1992-12-04 |
| Date Reported to FDA | 1992-12-04 |
| Date Reported to Mfgr | 1992-11-30 |
| Date Added to Maude | 1993-01-28 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDI-TECH |
| Generic Name | GLIDEX URETERAL STENT |
| Product Code | MER |
| Date Received | 1993-01-12 |
| Model Number | 548818-01 |
| Catalog Number | 22-530 |
| Lot Number | H 29410 |
| ID Number | N/I |
| Device Expiration Date | 1994-01-01 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 2119 |
| Manufacturer | MEDI-TECH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-01-12 |