MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-04-25 for MIC1333 manufactured by Sterilmed, Inc..
[73670420]
Contact with the account concerning the device was made. A response was received indicating that the device(s) will not be returned for a full investigation. Should the complaint device(s) ever be received in the future, an investigation will be conducted and a supplemental report will be sent. The device history report was not reviewed as no lot number was given.
Patient Sequence No: 1, Text Type: N, H10
[73670421]
It was reported that the jaw was bent and the wire was sticking out of the jaw. Broken inside patient. No patient injury or consequence reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2017-00008 |
| MDR Report Key | 6520638 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-04-25 |
| Date of Report | 2017-04-04 |
| Date Mfgr Received | 2017-04-04 |
| Date Added to Maude | 2017-04-25 |
| 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 | 5010 CHESHIRE PARKWAY SUITE 2 |
| Manufacturer City | PLYMOUTH MN 55446 |
| Manufacturer Country | US |
| Manufacturer Postal | 55446 |
| 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 | 2017-04-25 |
| 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 | 2017-04-25 |