MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-21 for COVIDIEN SOFSILK WAX COATED SUTURE GS-834 manufactured by Covidien Llc.
[180889332]
Surgeon was suturing tracheostomy in place with covidien 0 sofsilk gs-834. The tip of the needle broke off on the needle driver and then was taken off the field, the needle and the broken tip was removed from the field and confirmed by surgeon that the surgical site was clear. Not retained in pt. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093214 |
| MDR Report Key | 9744735 |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-02-05 |
| Date Added to Maude | 2020-02-24 |
| 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 |
| 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 | COVIDIEN SOFSILK WAX COATED SUTURE |
| Generic Name | SUTURE, NONABSORBABLE, SILK |
| Product Code | GAP |
| Date Received | 2020-02-21 |
| Model Number | GS-834 |
| Catalog Number | GS-834 |
| Lot Number | D8G0951X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-21 |