FDA Adverse Event
Injury
Summary report: N
LIQUIFIX FIX8
MDR report key: 21136776
·
Received January 13, 2025
Report
- Report Number
- 9617175-2025-00002
- Event Type
- Injury
- Date Received
- January 13, 2025
- Report Date
- January 11, 2025
- Manufacturer
- ADVANCED MEDICAL SOLUTIONS (PLYMOIUTH) LTD
- Product Code
- PLJ
- PMA / PMN Number
- P220024
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
PATIENT DEATAILS WERE NOT PROVIDED FROM THE REPORTER. INFOMRATION IS LIMITED AS THIS IS REPORTED THIRD PARTY VIA A REGISTRY.
Description of Event or Problem · 0
ACCORDING TO THE REPORT DURING THE INTERIM PROGRESS REPORT OF OUR US CLINICAL STUDY HERNIA RECURRENCE REQUIRING RE-OPERATION. TIME: WITHIN 30D OF SURGERY. DEVICE: LIQUIFIX FIX8 72014032. AS IT IS REPORTED VIA A REGISTRY, SPECIFIC PATIENT DETAILS AND/OR SITE WAS NOT REPORTED. EXCEPT THAT IT IS IN THE USA AND IT IS THE LIQUIFIX FIX8 72014032 DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 567298 | LIQUIFIX FIX8 | HERNIA MESH FIXATION | PLJ | ADVANCED MEDICAL SOLUTIONS (PLYMOIUTH) LTD | 72014032 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other| R |