FDA Adverse Event
Malfunction
Summary report: N
DERMAHOOK 1/2" HOOK
MDR report key: 2193617
·
Received July 13, 2011
Report
- Report Number
- 3003898360-2011-00294
- Event Type
- Malfunction
- Date Received
- July 13, 2011
- Date of Event
- June 15, 2011
- Report Date
- June 28, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- GDG
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PRODUCT HAS BEEN RECEIVED BY THE MFR, HOWEVER, THE INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A F/U REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: CUSTOMER STATES THAT THEY RECEIVED THE PRODUCT WITH BROKEN BANDS IN THE PACKAGE. NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DERMAHOOK 1/2" HOOK | ELASTIC RETRACTORS | GDG | TELEFLEX MEDICAL | NA | 01C1000168 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |