MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-05-14 for PILLING GOULIAN SKIN GRAFT KNIFE SET 050200 manufactured by Teleflex.
[2635800]
The event is reported as: during a procedure, while a resident was working on the pt's forearm, it appeared that the knife of the instrument protruded from the side during debridement and cut the pt's forearm. This resulted in a deep cut requiring stitches.
Patient Sequence No: 1, Text Type: D, B5
[9849430]
No device sample is available for investigation. No lot # available. Claim cannot be confirmed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1044475-2012-00044 |
| MDR Report Key | 2578304 |
| Report Source | 05,06 |
| Date Received | 2012-05-14 |
| Date of Report | 2012-04-27 |
| Date of Event | 2012-04-24 |
| Date Mfgr Received | 2012-04-27 |
| Date Added to Maude | 2012-09-21 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ELAINE BURKLE, RN |
| Manufacturer Street | P.O. BOX 12600 |
| Manufacturer City | RTP NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334957 |
| Manufacturer G1 | TELEFLEX |
| Manufacturer Street | 2917 WECK DRIVE |
| Manufacturer City | RTP NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PILLING GOULIAN SKIN GRAFT KNIFE SET |
| Generic Name | SKIN GRAFT KNIFE SET |
| Product Code | EMF |
| Date Received | 2012-05-14 |
| Catalog Number | 050200 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC 27709 US 27709 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-05-14 |