FDA Adverse Event
Malfunction
Summary report: N
DERMAHOOK 1/2"
MDR report key: 2093506
·
Received April 6, 2011
Report
- Report Number
- 3003898360-2011-00133
- Event Type
- Malfunction
- Date Received
- April 6, 2011
- Date of Event
- March 14, 2011
- Report Date
- March 15, 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 MANUFACTURER. HOWEVER, THE INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: CUSTOMER SAID, SHE RECEIVED PRODUCTS WITH BROKEN BANDS IN THE PACKAGE. NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DERMAHOOK 1/2" | DERMAHOOK | GDG | TELEFLEX MEDICAL | NA | 01C1000168 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |