FDA Adverse Event
Injury
Summary report: N
CARDIOCEL INTRACARDIAC PATCH
MDR report key: 10782293
·
Received November 3, 2020
Report
- Report Number
- 3012664855-2020-00011
- Event Type
- Injury
- Date Received
- November 3, 2020
- Date of Event
- October 14, 2015
- Report Date
- September 14, 2020
- Manufacturer
- ADMEDUS REGEN PTY LTD
- Product Code
- DXZ
- PMA / PMN Number
- K130872
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PRODUCT DID NOT MEET SURGEON'S REQUIREMENTS FOR FLEXIBILITY. PRODUCT APPEARED TO BE TOO STIFF SO WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1241546 | CARDIOCEL INTRACARDIAC PATCH | INTRACARDIAC PATCH | DXZ | ADMEDUS REGEN PTY LTD | C0404 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |