MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-04 for MEDTRONIC SOFSILK 0, V-20 SUTURE CVNGS834 manufactured by Medtronic / Covidien.
[182385959]
Physician was closing skin with sofsilk 0, v-20 suture. The needle tip broke while suturing. The tip of the needle was located. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093520 |
| MDR Report Key | 9792902 |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-02-05 |
| Date Added to Maude | 2020-03-05 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDTRONIC SOFSILK 0, V-20 SUTURE |
| Generic Name | SUTURE, NON ABSORBABLE, SILK |
| Product Code | GAP |
| Date Received | 2020-03-04 |
| Model Number | CVNGS834 |
| Lot Number | D860951X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC / COVIDIEN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-04 |