MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-25 for MEDLINE SUTURE REMOVAL TRAY MDS708555 manufactured by Medline Suture Removal Tray.
[50308811]
Patient Sequence No: 1, Text Type: N, H10
[50308812]
Scissors in suture removal kit had shard on handle and punctured dr on his right hand.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5818629 |
| MDR Report Key | 5818629 |
| Date Received | 2016-07-25 |
| Date of Report | 2016-07-12 |
| Date of Event | 2016-06-27 |
| Report Date | 2016-07-12 |
| Date Reported to FDA | 2016-07-12 |
| Date Reported to Mfgr | 2016-07-12 |
| Date Added to Maude | 2016-07-25 |
| 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 | 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 | MEDLINE SUTURE REMOVAL TRAY |
| Generic Name | KIT, SUTURE REMOVAL |
| Product Code | MCZ |
| Date Received | 2016-07-25 |
| Catalog Number | MDS708555 |
| Lot Number | 15QB5129 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE SUTURE REMOVAL TRAY |
| Manufacturer Address | ONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-07-25 |