FDA Adverse Event
Injury
Summary report: N
LIQUIBAND EXCEED
MDR report key: 11604088
·
Received April 1, 2021
Report
- Report Number
- 9617175-2021-00017
- Event Type
- Injury
- Date Received
- April 1, 2021
- Report Date
- June 25, 2021
- Manufacturer
- ADVANCED MEDICAL SOLUTIONS LTD
- Product Code
- MPN
- PMA / PMN Number
- K151182
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE FOLLOW-UP REPORT IS TO CORRECT THE ADVERSE EVENT TYPE IN B.2.
Description of Event or Problem · 0
ACCORDING TO THE REPORTER, FOLLOWING AN OPEN BREAST PROCEDURE, THE GLUE WAS USED TO SEAL THE INCISIONS AND THE PATIENT HAD ALLERGIC REACTIONS (DERMATITIS).
Additional Manufacturer Narrative · 1
WE CANNOT CONFIRM OR DENY THAT LIQUIBAND EXCEED CAUSED A SERIOUS INJURY. THERE IS A SMALL PERCENTAGE OF THE POPULATION WITH A NATURAL SENSITIVITY TO CYANOACRYLATE ADHESIVE. THIS IS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).
Description of Event or Problem · 1
SKIN REACTIONS USUALLY NOTICED 2 TO 3 WEEKS AFTER SURGERY. 11 COMPLAINTS OVER THE LAST 2 YEARS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 501132 | LIQUIBAND EXCEED | TOPICAL SKIN ADHESIVE | MPN | ADVANCED MEDICAL SOLUTIONS LTD | 72014008 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |