FDA Adverse Event
Injury
Summary report: N
BARRICAID ACD
MDR report key: 23526741
·
Received November 11, 2025
Report
- Report Number
- 3006232063-2025-00043
- Event Type
- Injury
- Date Received
- November 11, 2025
- Date of Event
- October 17, 2025
- Report Date
- November 11, 2025
- Manufacturer
- INTRINSIC THERAPEUTICS
- Product Code
- QES
- PMA / PMN Number
- P160050
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE DESCRIPTION OF THE EVENTS DETAILED IN THIS MDR REPRESENT INTRINSIC THERAPEUTIC'S UNDERSTANDING AT THE TIME OF SUBMISSION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR NEW INFORMATION SUBMITTED, ANOTHER FOLLOW-UP WILL BE COMPLETED. INTRINSIC THERAPEUTICS WILL CONTINUE TO MONITOR FOR UPDATES/TRENDS.
Description of Event or Problem · 0
THE PATIENT HAD A REHERNIATION, AND THE BARRICAID IMPLANT WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2645081 | BARRICAID ACD | BARRICAID | QES | INTRINSIC THERAPEUTICS | BAR-A8-10MM | 10102403 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |