FDA Adverse Event
Other
Summary report: N
MOTIFMESH SOFT TISSUE PATCH
MDR report key: 1211521
·
Received October 7, 2008
Report
- Report Number
- 3004859928-2008-00001
- Event Type
- Other
- Date Received
- October 7, 2008
- Report Date
- October 3, 2008
- Manufacturer
- PROXY BIOMEDICAL LTD.
- Product Code
- FTL
- PMA / PMN Number
- K052100
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
MOTIFMESH SOFT TISSUE PATCH INSTRUCTIONS FOR USE ALSO STATES THAT A POSSIBLE ADVERSE REACTION WITH THE USE OF ANY TISSUE DEFICIENTLY PROSTHESIS MAY INCLUDE BUT ARE NOT LIMITED TO ADHESIONS AND MECHANICAL DISRUPTIONS OF THE TISSUE AND/OR IMPLANT MATERIAL.
Description of Event or Problem · 1
IT WAS REPORTED VIA DISTRIBUTOR FROM DR. MEDICAL CENTER WITH REGARD TO MOTIFMESH. HE STATED THAT HE HAS GONE BACK IN ON 3 PATIENTS (WITH ISSUES) IMPLANTED WITH MOTIFMESH. HE STATED THAT THE ADHESIONS HAD OCCURRED ON THE POSTERIOR SIDE OF THE MESH THAT HAD TO BE "CHIPPED AWAY". THEY WERE NOT MILKY ADHESIONS. NO PATIENT INFORMATION WAS SUPPLIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MOTIFMESH SOFT TISSUE PATCH | SURGICAL MESH | FTL | PROXY BIOMEDICAL LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |