MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-10-04 for GOUGE 10MM-STANDARD & STRAIGHT 399.62 manufactured by Wrights Lane Synthes Usa Products Llc.
[122810779]
Additional narrative: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. 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.
Patient Sequence No: 1, Text Type: N, H10
[122810780]
It was reported that upon receipt of the order on (b)(6) 2018, it was noted that the tip of a gouge 10mm-standard & straight was broken off. There was no patient involvement. This report is for one (1) gouge 10mm-standard & straight. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-54172 |
| MDR Report Key | 7936025 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-10-04 |
| Date of Report | 2018-09-13 |
| Date Mfgr Received | 2018-11-05 |
| Device Manufacturer Date | 2018-09-03 |
| Date Added to Maude | 2018-10-04 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES TUTTLINGEN |
| Manufacturer Street | UNTER HASSLEN 5 |
| Manufacturer City | TUTTLINGEN 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GOUGE 10MM-STANDARD & STRAIGHT |
| Generic Name | GOUGE,SURGICAL,GEN & PLASTIC SURGERY |
| Product Code | GDH |
| Date Received | 2018-10-04 |
| Returned To Mfg | 2018-10-02 |
| Model Number | 399.62 |
| Catalog Number | 399.62 |
| Lot Number | T168808 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2018-10-04 |