FDA Adverse Event
Injury
Summary report: N
MESO BIOMATRIX
MDR report key: 6118763
·
Received November 21, 2016
Report
- Report Number
- 2530154-2016-00016
- Event Type
- Injury
- Date Received
- November 21, 2016
- Report Date
- November 21, 2016
- Manufacturer
- DSM BIOMEDICAL
- Product Code
- OXH
- PMA / PMN Number
- K090134
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER HAS MADE NUMEROUS ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WITHOUT SUCCESS. THERE HAS BEEN NO DESIGN HISTORY REVIEW AS NO PRODUCT INFORMATION HAS BEEN PROVIDED TO DATE. DEVICE NOT RETURNED.
Description of Event or Problem · 1
THE SURGEON REPORTED THAT, POST-MASTECTOMY, A PATIENT RETURNED TO THE OPERATING ROOM FOR IMPLANT EXCHANGE AND EXPLANTATION OF THE MESO BIOMATRIX. HE STATED THAT HE SAW A "JELLY-LIKE" SUBSTANCE DURING THE EXPLANTATION. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 769474 | MESO BIOMATRIX | MESH, SURGICAL, COLLAGEN, PLASTIC AND RECONSTRUCTIVE SURGERY | OXH | DSM BIOMEDICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |