MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-05-15 for AMERICAN ORTHOPAEDIC 0295-200 manufactured by Bsn Medical, Inc.
[3494339]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10772250]
Saw was returned, evaluation an tested for electrical and functional safety. All tests passed, meeting final specifications. Follow up communications with initial reporter indicates they completed their internal investigation and had determined (per email/phone call from "(b)(6)", engineering administrator) that product had indeed "been operating correctly, no functioning issue related to product and that it was a technique problem. " investigation closed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1043537-2013-00001 |
| MDR Report Key | 3149727 |
| Report Source | 06 |
| Date Received | 2013-05-15 |
| Date of Report | 2013-02-27 |
| Date of Event | 2013-02-18 |
| Report Date | 2013-02-01 |
| Date Reported to FDA | 2013-02-01 |
| Date Mfgr Received | 2013-03-13 |
| Device Manufacturer Date | 2009-06-01 |
| Date Added to Maude | 2013-06-10 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CARROLL HOYLE |
| Manufacturer Street | 100 BEIERSDORF DR |
| Manufacturer City | RUTHERFORD COLLEGE NC 28671 |
| Manufacturer Country | US |
| Manufacturer Postal | 28671 |
| Manufacturer Phone | 8288795100 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMERICAN ORTHOPAEDIC |
| Generic Name | SAW |
| Product Code | LGH |
| Date Received | 2013-05-15 |
| Model Number | 0295-200 |
| ID Number | CE# 93304 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BSN MEDICAL, INC |
| Manufacturer Address | 100 BEIERSDORF DR RUTHERFORD COLLEGE NC 28671 US 28671 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-15 |