MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-28 for ETHMCM30 manufactured by Sterilmed, Inc..
[146218090]
The reprocessed ligaclip failed. The physician tried to control bleeding with clip applier. The reprocessed clip applier was not functioning correctly and a brand new clip applier was opened.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8645209 |
| MDR Report Key | 8645209 |
| Date Received | 2019-05-28 |
| Date of Report | 2019-05-15 |
| Date of Event | 2019-05-14 |
| Report Date | 2019-05-15 |
| Date Reported to FDA | 2019-05-15 |
| Date Reported to Mfgr | 2019-05-28 |
| Date Added to Maude | 2019-05-28 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | NA |
| Generic Name | CLIP, IMPLANTABLE, REPROCESSED |
| Product Code | NMJ |
| Date Received | 2019-05-28 |
| Model Number | ETHMCM30 |
| Catalog Number | ETHMCM30 |
| Lot Number | 2058827 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | 5010 CHESHIRE PKWY N STE 2 PLYMOUTH MN 55446 US 55446 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-28 |