MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-08-19 for CHROMIC SUTURE NEEDLE manufactured by Ethicon.
[911]
Patient had moderate amount of bright, red bleeding post surgical procedure. Patient required suturing. Tip end of needle broke inside vagina. Hemostatis obtained. Needle tip not recoveredinvalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. Invalid data - regarding 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: none or unknown. Results of evaluation: none or unknown. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: none or unknown. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3061 |
| MDR Report Key | 3061 |
| Date Received | 1992-08-19 |
| Date of Report | 1992-01-24 |
| Date of Event | 1992-01-14 |
| Date Facility Aware | 1992-01-14 |
| Report Date | 1992-01-24 |
| Date Reported to Mfgr | 1992-01-24 |
| Date Added to Maude | 1993-04-06 |
| 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 | CHROMIC SUTURE NEEDLE |
| Product Code | HAS |
| Date Received | 1992-08-19 |
| ID Number | SIZE 0 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 2862 |
| Manufacturer | ETHICON |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1992-08-19 |