MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-08 for GOULIAN GUARD .010 GAUGE 050204 manufactured by Teleflex Medical.
[59864079]
(b)(4). The device has not been returned for investigation. The manufacturer will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[59864080]
The surgeon was attempting to perform a split-thickness skin graft with a 0. 010 depth weck blade, but it started to take a full thickness graft. He immediately stopped and sutured the laceration closed. Surgeon thinks the blade guard was out of calibration. The patient's condition was reported as unknown.
Patient Sequence No: 1, Text Type: D, B5
[63649109]
(b)(4). Device history record was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns. No concerns were noted with reference to goulian guards. A visual inspection of the product involved in the complaint could not be conducted since the product was not returned. No confirmed complaints were received in this range with the same issue. No further investigation is possible without a physical sample.
Patient Sequence No: 1, Text Type: N, H10
[63649110]
The surgeon was attempting to perform a split-thickness skin graft with a 0. 010 depth weck blade, but it started to take a full thickness graft. He immediately stopped and sutured the laceration closed. Surgeon thinks the blade guard was out of calibration. The patient's condition was reported as unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011137372-2016-00336 |
| MDR Report Key | 6086122 |
| Date Received | 2016-11-08 |
| Date of Report | 2016-10-31 |
| Date of Event | 2016-09-14 |
| Date Mfgr Received | 2016-12-05 |
| Date Added to Maude | 2016-11-08 |
| 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 | JASMINE BROWN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9193614124 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GOULIAN GUARD .010 GAUGE |
| Generic Name | KNIFE, SURGICAL |
| Product Code | EMF |
| Date Received | 2016-11-08 |
| Catalog Number | 050204 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-11-08 |