MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-07-22 for PROLENE 2.0 SURGICAL SUTURE NEEDLE CT-2 manufactured by Ethicon, Inc..
[3588]
While performing left inguinal hernia repair with suture needle in question, it was noted that tip of needle was missing. It could not be located in the surgical wound or surrounding sterile field. X-rays taken immediately post-op were negative. Device 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 not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: yes. Corrective actions: device discarded, none or unknown. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6796 |
| MDR Report Key | 6796 |
| Date Received | 1993-07-22 |
| Date of Report | 1993-02-05 |
| Date of Event | 1993-02-01 |
| Date Facility Aware | 1993-02-01 |
| Report Date | 1993-02-05 |
| Date Reported to Mfgr | 1993-02-05 |
| Date Added to Maude | 1993-10-15 |
| 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 | PROLENE 2.0 SURGICAL SUTURE NEEDLE |
| Product Code | HAS |
| Date Received | 1993-07-22 |
| Model Number | CT-2 |
| Device Availability | N |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 6479 |
| Manufacturer | ETHICON, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-07-22 |