MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-04-20 for MIC1333 manufactured by Sterilmed, Inc..
[73274519]
It was reported that the device will not be returned to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[73274520]
It was reported that the jaw was bent and the wire was sticking out of the jaw. The surgeon attempted to fix it and determined that it was not usable. It was reported that the product will not be returned for to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2017-00004 |
| MDR Report Key | 6507830 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-04-20 |
| Date of Report | 2017-04-04 |
| Date Mfgr Received | 2017-04-04 |
| Date Added to Maude | 2017-04-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | JASON ANDERSON |
| Manufacturer Street | 5101 CHESHIRE PARKWAY SUITE 2 |
| Manufacturer City | PLYMOUTH MN 55446 |
| Manufacturer Country | US |
| Manufacturer Postal | 55446 |
| Manufacturer Phone | 7634888348 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | FORCEPS, BIOPSY, NON-ELECTRIC, REPROCESSED |
| Product Code | NON |
| Date Received | 2017-04-20 |
| Model Number | MIC1333 |
| Catalog Number | MIC1333 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | 11400 73RD AVE N MAPLE GROVE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-20 |