MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2014-07-18 for TISCHLEY BPSY FCPS 9-1/4IN WITH LOCK 301442WL manufactured by Integra York, Pa Inc.
[18033066]
Customer initially reports the device was just purchased, not sharp, caused pt pain during procedure. Date: (b)(6) 2014 nurse practitioner confirms having caused the pt pain with the device when taking cervical biopsy. Sample taken successfully, otherwise no harm done.
Patient Sequence No: 1, Text Type: D, B5
[18132241]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2014-00051 |
| MDR Report Key | 3979342 |
| Report Source | 06,08 |
| Date Received | 2014-07-18 |
| Date of Report | 2014-06-24 |
| Date of Event | 2014-06-18 |
| Date Mfgr Received | 2014-06-25 |
| Date Added to Maude | 2014-08-14 |
| 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 | 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 | TISCHLEY BPSY FCPS 9-1/4IN WITH LOCK |
| Generic Name | PFM07 |
| Product Code | HCZ |
| Date Received | 2014-07-18 |
| Catalog Number | 301442WL |
| Lot Number | T01-81311072 |
| 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 | 1. Other | 2014-07-18 |