MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-06 for HENRY SCHEIN SUTURE REMOVAL KIT manufactured by Henry Schein, Inc..
[174175978]
Suture removal kit was used to remove sutures on a pt and the scissors were bent when they were pulled from packaging and unable to cut the sutures. Another kit was obtained and there was no harm to the pt. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092060 |
| MDR Report Key | 9559050 |
| Date Received | 2020-01-06 |
| Date of Report | 2020-01-03 |
| Date of Event | 2020-01-02 |
| Date Added to Maude | 2020-01-07 |
| 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 | HENRY SCHEIN SUTURE REMOVAL KIT |
| Generic Name | SUTURE REMOVAL KIT |
| Product Code | MCZ |
| Date Received | 2020-01-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HENRY SCHEIN, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-06 |