MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-17 for STR375-564-000 manufactured by Sterilmed, Inc..
[80283603]
(b)(6). No devices reached sterilmed quality department for a full investigation. As such the complaint was handled as a no device return. Should the device be received in the future the investigation may be re-opened at that time. Previous submission included a typographical error. Manufacturer report number was originally reported as 21304070-2017-00059 instead of the correct #2134070-2017-00059.
Patient Sequence No: 1, Text Type: N, H10
[80283604]
Teeth broke off of shaver blade.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2017-00059 |
| MDR Report Key | 6718816 |
| Date Received | 2017-07-17 |
| Date of Report | 2017-07-17 |
| Date of Event | 2017-05-22 |
| Date Mfgr Received | 2017-05-23 |
| Date Added to Maude | 2017-07-17 |
| 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 | SEAN FITZSIMMONS |
| Manufacturer Street | 5010 CHESHIRE PARKWAY STE 2 |
| Manufacturer City | PLYMOUTH 55446 |
| Manufacturer Country | US |
| Manufacturer Postal | 55446 |
| Manufacturer G1 | STERILMED, INC. |
| Manufacturer Street | 5010 CHESHIRE PARKWAY STE 2 |
| Manufacturer City | PLYMOUTH 55446 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55446 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NA |
| Generic Name | ARTHROSCOPE |
| Product Code | NLM |
| Date Received | 2017-07-17 |
| Model Number | STR375-564-000 |
| Catalog Number | STR375-564-000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | 11400 73RD AVE MAPLE GROVE MN 55369 US 55369 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-17 |