FDA Adverse Event
Malfunction
Summary report: N
LIQUIBAND RAPID
MDR report key: 10763698
·
Received October 30, 2020
Report
- Report Number
- 9617175-2020-00040
- Event Type
- Malfunction
- Date Received
- October 30, 2020
- Date of Event
- September 30, 2020
- Report Date
- October 30, 2020
- Manufacturer
- ADVANCED MEDICAL SOLUTIONS LTD
- Product Code
- MPN
- PMA / PMN Number
- K183570
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO PATIENT INJURY, REPORTING AS A PRECAUTIONARY MEASURE.
Description of Event or Problem · 1
STAFF REPORTED TWO INSTANCES OF THE LIQUIBAND RAPID PRODUCT FAILING, BOTH INSTANCES CAME FROM THE INTERVENTIONAL RADIOLOGY DEPARTMENT AND BOTH INSTANCES INVOLVED THE TIP OF THE DEVICE "POPPING OFF" AND SPILLING ADHESIVE. NO PATIENT OR NEGATIVE CLINICAL OUTCOME WAS NOTED. HOWEVER, THIS EVENT IS BEING REPORTED AS A PRECAUTIONARY MEASURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1231636 | LIQUIBAND RAPID | TOPICAL SKIN ADHESIVE | MPN | ADVANCED MEDICAL SOLUTIONS LTD | 72014029 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |