MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2019-02-04 for AWL manufactured by Wrights Lane Synthes Usa Products Llc.
[135011510]
This report is for one (1) unknown awl. Part#, lot# and udi # is not available. Device is not expected to be returned for manufacturer review/investigation. This report is for one (1) unknown awl. Pma/510(k) number is not available. Product was not returned. Device history records review could not be completed without lot number. Based on the information available, it has been determined that no corrective and preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Reported under maude mw5082249: device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. [(b)(4); mw5082249].
Patient Sequence No: 1, Text Type: N, H10
[135011511]
This report is against user facility medwatch number mw5082249. The only information contained in this report is correction or additional information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2019-56299 |
| MDR Report Key | 8302360 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2019-02-04 |
| Date of Report | 2019-01-16 |
| Date Mfgr Received | 2019-02-05 |
| Date Added to Maude | 2019-02-04 |
| 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 | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHT LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | AWL |
| Product Code | HWJ |
| Date Received | 2019-02-04 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHTS LANE SYNTHES USA PRODUCTS LLC |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-04 |