MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07,08 report with the FDA on 2012-06-20 for PILLING KNIFE HANDLE 3 352950 manufactured by Teleflex.
[2725713]
The event is reported as: "alleged issue: blades do not go on/off of handle easily. Issue was reported prior to use on a pt. " no pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
[10117761]
The device sample was not received by the mfr at time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1044475-2012-00080 |
| MDR Report Key | 2627793 |
| Report Source | 06,07,08 |
| Date Received | 2012-06-20 |
| Date of Report | 2012-06-08 |
| Date Mfgr Received | 2012-06-08 |
| Date Added to Maude | 2012-10-12 |
| 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 | JASMINE BROWN |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | RTP NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9193614124 |
| Manufacturer G1 | TELEFLEX |
| Manufacturer Street | 2917 WECK DR. |
| 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 | 2012-06-20 |
| Catalog Number | 352950 |
| Lot Number | L1 |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-06-20 |