MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-02-25 for TOWNLEY FEMUR CALIPER 4-1/2 275600 manufactured by Integra York, Pa Inc..
[17334180]
Customer medwatch #0504140000-2014-8011 reports: the femoral head explant was measured using the calipers on the outside edges of the implant. The markings at that time measured 38 outside and 46 inside. Markings are confusing and not logical to think the outside measurement appears to be larger than the inside marking.
Patient Sequence No: 1, Text Type: D, B5
[17451865]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2015-00008 |
| MDR Report Key | 4554341 |
| Report Source | 06 |
| Date Received | 2015-02-25 |
| Date of Report | 2015-01-29 |
| Date of Event | 2015-11-11 |
| Date Mfgr Received | 2015-01-29 |
| Date Added to Maude | 2015-03-27 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SANDRA LEE |
| Manufacturer Street | 315 ENTERPRISE DR. |
| Manufacturer Phone | 6099366828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOWNLEY FEMUR CALIPER 4-1/2 |
| Generic Name | NA |
| Product Code | FTY |
| Date Received | 2015-02-25 |
| Catalog Number | 275600 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-25 |