MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-11 for SUTURE REMOVAL KIT manufactured by Centurion Medical Products.
[113878438]
Upon opening an e. R. Suture removal tray, rust was found on the scissors. I decided to examine all suture removal trays and found that in a suture removal kit, there was rust on both the forceps and the scissors.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078340 |
| MDR Report Key | 7681269 |
| Date Received | 2018-07-11 |
| Date of Report | 2018-07-09 |
| Date of Event | 2018-06-27 |
| Date Added to Maude | 2018-07-12 |
| 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 | 0 |
| Brand Name | SUTURE REMOVAL KIT |
| Generic Name | SUTURE REMOVAL KIT |
| Product Code | MCZ |
| Date Received | 2018-07-11 |
| Lot Number | 2017090501 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CENTURION MEDICAL PRODUCTS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-11 |