FDA Adverse Event
Malfunction
Summary report: N
VISISTAT 35R 6/BOX
MDR report key: 14606079
·
Received June 6, 2022
Report
- Report Number
- 3003898360-2022-00205
- Event Type
- Malfunction
- Date Received
- June 6, 2022
- Date of Event
- May 19, 2022
- Report Date
- May 19, 2022
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- QQS
- UDI-DI
- 14026704631770
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
(B)(4). THE DEVICE HISTORY REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED.
Description of Event or Problem · 0
HAPPENED WITH 2 FEMALE PATIENTS: AFTER A SURGICAL INTERVENTION, THEY CAME BACK TO THE HOSPITAL BECAUSE THEY COMPLAINED THAT THE STAPLES DO NOT CLOSE PROPERLY THE WOUND, STAPLES REMOVED WHEN DRESSING GOT REMOVED AND THUS THE WOUND WAS NOT CLOSED PROPERLY. THERE WAS A DELAY IN WOUND HEALING. NO REPORTED MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 541998 | VISISTAT 35R 6/BOX | STAPLE, REMOVABLE (SKIN) | QQS | TELEFLEX MEDICAL | IPN028492 | UNKNOWN | 14026704631770 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |