MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-10-05 for UNKNOWN manufactured by Ethicon.
[1084]
While suturing the patient, it was noted that the tip of the needle was no longer on the suture. X-ray was taken of the patient to ensure that the tip was not lodged in soft tissue. No further treatment was indicateddevice labeled for single use. Patient medical status prior to event: unknown. 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: none or unknown. Results of evaluation: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: yes. Corrective actions: none or unknown. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1480 |
| MDR Report Key | 1480 |
| Date Received | 1992-10-05 |
| Date of Report | 1992-09-17 |
| Date of Event | 1992-09-15 |
| Date Facility Aware | 1992-09-15 |
| Report Date | 1992-09-17 |
| Date Reported to FDA | 1992-09-17 |
| Date Reported to Mfgr | 1992-09-17 |
| Date Added to Maude | 1992-10-15 |
| 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 | UNKNOWN |
| Generic Name | VICRYL PS-2 |
| Product Code | GDL |
| Date Received | 1992-10-05 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| ID Number | UNKNOWN |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 1417 |
| Manufacturer | ETHICON |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1992-10-05 |