MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-06-07 for PILLING KNIFE HANDLE 3 352950 manufactured by Teleflex.
[2766457]
The event is reported as: customer alleges it is very difficult to blade on and off the handle. A nurse's finger got cut when she tried to remove the blade. Unk if she used a forcep, as is protocol, to remove it. This occurred before pt use.
Patient Sequence No: 1, Text Type: D, B5
[9924275]
Sample has not been received by manufacturer in time for this report. A follow up report will be submitted when completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1044475-2012-00060 |
| MDR Report Key | 2617817 |
| Report Source | 05,06 |
| Date Received | 2012-06-07 |
| Date of Report | 2012-05-16 |
| Date Mfgr Received | 2012-05-16 |
| Date Added to Maude | 2012-10-05 |
| 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 | 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 KNIFE HANDLE 3 |
| Generic Name | KNIFE HANDLE |
| Product Code | GDZ |
| Date Received | 2012-06-07 |
| Catalog Number | 352950 |
| Lot Number | H29135295019 |
| 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 |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC 27709 US 27709 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-06-07 |