FDA Adverse Event
Malfunction
Summary report: N
VISISTAT 35W NON-STERILE
MDR report key: 14674812
·
Received June 13, 2022
Report
- Report Number
- 3003898360-2022-00225
- Event Type
- Malfunction
- Date Received
- June 13, 2022
- Date of Event
- May 23, 2022
- Report Date
- May 26, 2022
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- QQS
- UDI-DI
- 34026704631798
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
QN#(B)(4). THE DEVICE HISTORY REVIEW FOR THE PRODUCT VISISTAT 35W NON-STERILE LOT# 73E2100232 INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE COMPLAINT.
Description of Event or Problem · 0
THE ORHOPIDS FIND THAT THE STAPLES DO NOT CLOSE NICELY AND SO THE WOUND SUBSEQUENTLY DOES NOT CLOSE FROM SKIN STAPLER 528236. CLINICAL CONSEQUENCES: INFECTIONS HAVE OCCURRED IN THE PATIENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1249499 | VISISTAT 35W NON-STERILE | STAPLE, REMOVABLE (SKIN) | QQS | TELEFLEX MEDICAL | IPN914814 | 73E2100232 | 34026704631798 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |