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 2017-04-24 for MIC1333 manufactured by Sterilmed, Inc..
[73559966]
Contact with the account concerning the device was made. A response was received indicating that the device(s) will not be returned to the manufacturer for a full investigation. The dhr was reviewed and no discrepancies were found.
Patient Sequence No: 1, Text Type: N, H10
[73559967]
It was reported that the device broke while in the patient. Additional details were requested but no additional information is available. This was noted as a general complaint of this happening again (that was undocumented and unreported to the manufacturer, from a previous complaint of the same issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2017-00006 |
| MDR Report Key | 6516707 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-04-24 |
| Date of Report | 2017-03-28 |
| Date of Event | 2017-03-27 |
| Date Mfgr Received | 2017-03-28 |
| Device Manufacturer Date | 2016-10-25 |
| Date Added to Maude | 2017-04-24 |
| 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 |
| 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 | 2017-04-24 |
| Model Number | MIC1333 |
| Catalog Number | MIC1333 |
| Lot Number | 1974707 |
| Device Expiration Date | 2017-10-25 |
| 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 | 2017-04-24 |