FDA Adverse Event
Malfunction
Summary report: N
FOGARTY - HYDRAGRIP SURGICAL - CLAMP INSERTS
MDR report key: 2242191
·
Received September 9, 2011
Report
- Report Number
- 2015691-2011-16164
- Event Type
- Malfunction
- Date Received
- September 9, 2011
- Date of Event
- August 16, 2011
- Report Date
- August 19, 2011
- Manufacturer
- EDWARDS LIFESCIENCES, PR
- Product Code
- DXC
- PMA / PMN Number
- PREAMENDMENT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HYDRA33 INSERT SET WAS RETURNED FOR EVALUATION IN A SEALED POUCH. A VISUAL EXAMINATION CONFIRMED THAT A HAIR IS SEALED INSIDE THE TYVEK POUCH. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT THE DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. THE CUSTOMER REPORT WAS CONFIRMED. AN AWARENESS TRAINING IS BEING CONDUCTED AT THE MANUFACTURING SITE TO PREVENT RECURRENCE OF THIS TYPE OF COMPLAINT.
Description of Event or Problem · 1
IT WAS REPORTED THAT "HAIR-LIKE UNKNOWN MATERIAL WAS OBSERVED INSIDE THE PACKAGE BEFORE USE." NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FOGARTY - HYDRAGRIP SURGICAL - CLAMP INSERTS | CLAMP INSERTS | DXC | EDWARDS LIFESCIENCES, PR | HYDRA33 | 59030916 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |