MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-12-30 for TROCAR manufactured by Ethicon.
[15713350]
Eighteen year old admitted 10/19/ for lap chole. Op 10/20: lap chole. Patient returned to or same day for repair lacerated abdominal aortainvalid data - regarding single use labeling of device. 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. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: maybe. Corrective actions: device returned to manufacturer/dealer/distributor. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3559 |
| MDR Report Key | 3559 |
| Date Received | 1992-12-30 |
| Date of Event | 1992-10-20 |
| Date Facility Aware | 1992-10-20 |
| Date Reported to Mfgr | 1992-12-14 |
| Date Added to Maude | 1993-04-23 |
| 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 | TROCAR |
| Product Code | FBQ |
| Date Received | 1992-12-30 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Implant Flag | * |
| Device Sequence No | 1 |
| Device Event Key | 3301 |
| Manufacturer | ETHICON |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1992-12-30 |