FDA Adverse Event
Malfunction
Summary report: N
VISISTAT 35R 6/BOX
MDR report key: 16818553
·
Received April 26, 2023
Report
- Report Number
- 3003898360-2023-00656
- Event Type
- Malfunction
- Date Received
- April 26, 2023
- Date of Event
- April 10, 2023
- Report Date
- April 10, 2023
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- QQS
- UDI-DI
- 04026704418190
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
QN#(B)(4). UPON FURTHER REVIEW, IT WAS DETERMINED THAT THIS COMPLAINT WAS CREATED IN ERROR, THUS, THE INITIAL MDR SUBMITTED ON 26 APRIL 2023 SHOULD BE RETRACTED. OTHER REMARKS: N/A. CORRECTED DATA: N/A.
Additional Manufacturer Narrative · 0
QN# (B)(4).N/A. OTHER REMARKS: N/A. CORRECTED DATA: N/A.
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING INSPECTION/FUNCTIONAL TESTING, THE STAPLER JAMMED. NO PATIENT INVOLVEMENT.
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING INSPECTION/FUNCTIONAL TESTING, THE STAPLER JAMMED. NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1080742 | VISISTAT 35R 6/BOX | STAPLE, REMOVABLE (SKIN) | QQS | TELEFLEX MEDICAL | IPN008818 | 71F21L0110 | 04026704418190 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |