MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-07-18 for FERREIRA BREAST RETRACTOR W/FIBER OPTICS P895FO manufactured by Integra York Pa Inc.
[4801908]
Customer initially reports that a patient was mildly burned during procedure. Patient is fine. Customer not sure if retractor was used in surgery. On (b)(6) 2014, the customer promised to answer email questions. Multiple requests were made, but no responses were received.
Patient Sequence No: 1, Text Type: D, B5
[12349487]
The device involved in the reported incident is not available for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2014-00052 |
| MDR Report Key | 4030343 |
| Report Source | 06 |
| Date Received | 2014-07-18 |
| Date of Report | 2014-06-20 |
| Date Mfgr Received | 2014-06-20 |
| Date Added to Maude | 2014-09-02 |
| 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 DRIVE |
| Manufacturer Phone | 6099386828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FERREIRA BREAST RETRACTOR W/FIBER OPTICS |
| Generic Name | FIBER OPTIC INSTRUMENTATION |
| Product Code | FDG |
| Date Received | 2014-07-18 |
| Catalog Number | P895FO |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK PA INC |
| Manufacturer Address | YORK PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 9300 | 1. Other | 2014-07-18 |