FDA Adverse Event
Malfunction
Summary report: N
FIGULLA FLEX II ASD OCCLUDER
MDR report key: 22951099
·
Received September 3, 2025
Report
- Report Number
- 3014616394-2025-00017
- Event Type
- Malfunction
- Date Received
- September 3, 2025
- Date of Event
- August 1, 2025
- Report Date
- September 3, 2025
- Manufacturer
- OCCLUTECH GMBH
- Product Code
- OZG
- UDI-DI
- 04260182520710
- PMA / PMN Number
- P200032
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
A1-A4 IS UNKNOWN. THE REVIEW OF THE BATCH RECORD AND INSPECTION PROTOCOLS OF THE REPORTED DEVICE REVEALED NO DEVIATION. ALL QC CRITERIA WERE WITHIN SPECIFICATION ACCORDING TO THE BATCH RECORD.
Additional Manufacturer Narrative · 0
THE DEVICE WAS NOT RETURNED BY THE CUSTOMER; THEREFORE NO INVESTIGATION COULD BE PERFORMED. THE FINAL ROOT CAUSE REMAINS UNKNOWN.
Description of Event or Problem · 0
RIGHT DISC LOOKED ABNORMALLY SHAPED AND WOULDN'T INFLATE/DEFLATE OUTSIDE OF THE BODY. NEW DEVICE WAS TAKEN AND IMPLANTED WITHOUT ANY ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1733813 | FIGULLA FLEX II ASD OCCLUDER | ASD OCCLUDER | OZG | OCCLUTECH GMBH | 29ASD24 | 2413292416 | 04260182520710 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |