FDA Adverse Event
Malfunction
Summary report: N
WECK VISISTAT SKIN STAPLER
MDR report key: 2509260
·
Received March 22, 2012
Report
- Report Number
- 3003898360-2012-00091
- Event Type
- Malfunction
- Date Received
- March 22, 2012
- Date of Event
- February 3, 2012
- Report Date
- February 29, 2012
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- GDT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
THE EVENT WAS REPORTED AS THE FOLLOWING: THE STAPLES POORLY MAINTAINS THE SCARS (TWO PARTS) AFTER A CAESAREAN INTERVENTION. THE STAPLES OPENED A FEW DAYS AFTER THEY WERE APPLIED. NO REPORT OF STAPLES FALLING INTO THE PATIENT'S SURGICAL SITE. NO PT INJURY OR INTERVENTION REPORTED. PT CONDITION IS FINE, AS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WECK VISISTAT SKIN STAPLER | SKIN STAPLER | GDT | TELEFLEX MEDICAL | 0E1100135 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |