MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-12-03 for 5377240 manufactured by Surgi-tech.
[1480]
Patient to hospital for routine ureteral stent replacement - every 3 mos - last seen 5/11/92. Upon cystoscope examination approximately 1/3 of stent placed 5/11/92 was in anal pelvis, 2/3 in bladder. Left side stent still in place. Broken stent changed without difficultydevice 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. Imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: yes. Corrective actions: no data. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1964 |
| MDR Report Key | 1964 |
| Date Received | 1992-12-03 |
| Date of Report | 1992-09-10 |
| Date of Event | 1992-08-21 |
| Date Facility Aware | 1992-09-10 |
| Report Date | 1992-09-10 |
| Date Reported to FDA | 1992-09-10 |
| Date Reported to Mfgr | 1992-09-10 |
| Date Added to Maude | 1992-12-22 |
| 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 |
| Product Code | MER |
| Date Received | 1992-12-03 |
| Catalog Number | 5377240 |
| Lot Number | G452-90H/G379-90E |
| Operator | OTHER |
| Device Availability | Y |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 1828 |
| Manufacturer | SURGI-TECH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1992-12-03 |