FDA Adverse Event
Injury
Summary report: N
PHYSIOMESH
MDR report key: 3122725
·
Received May 21, 2013
Report
- Report Number
- 2210968-2013-05748
- Event Type
- Injury
- Date Received
- May 21, 2013
- Report Date
- April 30, 2013
- Manufacturer
- ETHICON, INC
- Product Code
- FTL
- PMA / PMN Number
- K093932
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4) - ADHESIONS OCCURRED. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT ROBOTIC LAPAROSCOPIC VENTRAL HERNIA REPAIR ON AND UNKNOWN DATE AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN. ON (B)(6) 2013 A ROBOTIC DIAGNOSTIC LAPAROSCOPY WAS DONE. DURING THE PROCEDURE IT WAS NOTED THAT THE MESH HAD ADHERED TO THE OMENTUM. A LYSIS OF THE ADHESIONS WAS DONE. ADDITIONAL INFORMATION TO BE REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 224703 | PHYSIOMESH | MESH, SURGICAL, POLYMERIC | FTL | ETHICON, INC | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |