FDA Adverse Event
Malfunction
Summary report: N
VIALITY¿ LIPOASPIRATE WASH SYSTEM
MDR report key: 17652086
·
Received August 30, 2023
Report
- Report Number
- 1651189-2023-05436
- Event Type
- Malfunction
- Date Received
- August 30, 2023
- Date of Event
- June 15, 2023
- Report Date
- August 30, 2023
- Manufacturer
- SIENTRA INC
- Product Code
- QKL
- PMA / PMN Number
- BK190433
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
SIENTRA COMPLAINT #: (B)(4). PATIENT AGE DEFAULTED TO "99" AS NO PATIENT INFORMATION WAS PROVIDED. SIENTRA WAS UNABLE TO PERFORM AN EVALUATION AS THE DEVICE WAS DISCARDED BY THE CUSTOMER. SIENTRA WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 0
SUCTION PRESSURE FAILED. LIPOASPIRATE LEAKED ONTO FOAM PRIOR TO THE DRAWER BEING PULLED. SURGEON MADE MANY ATTEMPTS TO USE VIALITY AND EVENTUALLY HAD TO RETREAT TO OLD CONTAINMENT METHOD. PRODUCT WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1398555 | VIALITY¿ LIPOASPIRATE WASH SYSTEM | FAT TRANSFER | QKL | SIENTRA INC | VIALITY-1400 | A41744 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 99 YR | Unknown |