FDA Adverse Event
Malfunction
Summary report: N
NON-ADHERANT ANTIMICROBIAL ALGINATE DRESSING
MDR report key: 8054922
·
Received November 9, 2018
Report
- Report Number
- 8044178-2018-00002
- Event Type
- Malfunction
- Date Received
- November 9, 2018
- Report Date
- November 9, 2018
- Manufacturer
- ADVANCED MEDICAL SOLUTIONS LTD
- Product Code
- FRO
- PMA / PMN Number
- K081363
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BASED UPON THE AVAILABLE INFORMATION THE INCIDENT IS DEEMED A REPORTABLE MALFUNCTION. THE DRESSING WAS NOT USED. THE PRIMARY PACKAGING AND SECONDARY PACKAGING INCLUDES STATEMENT AND/OR SYMBOLS "DO NOT USE IF PACKAGING IS DAMAGED".
Description of Event or Problem · 1
"DURING ADDITIONAL COUNTRY SPECIFIC LABELLING FOR KUWAIT, THREE POUCHES WERE FOUND WITH PRODUCT TRAPPED THROUGH THE SEAL" PHOTOS DEPICTING THE REPORTED COMPLAINT WERE PROVIDED BY THE COMPLAINANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 893902 | NON-ADHERANT ANTIMICROBIAL ALGINATE DRESSING | ANTIMICROBIAL WOUND DRESSING | FRO | ADVANCED MEDICAL SOLUTIONS LTD | 32923 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |