FDA Adverse Event
Injury
Summary report: N
SURGIMESH XB
MDR report key: 24527651
·
Received March 5, 2026
Report
- Report Number
- 3015860534-2026-00001
- Event Type
- Injury
- Date Received
- March 5, 2026
- Report Date
- March 5, 2026
- Manufacturer
- CHAMBERLAIN TECHNOLOGIES LLC
- Product Code
- FTL
- UDI-DI
- 00850011929032
- PMA / PMN Number
- K072974
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
ON 05-FEB-2026, CHAMBERLAIN TECHNOLOGIES BECAME AWARE OF A COMPLAINT INVOLVING A PREVIOUSLY IMPLANTED SURGIMESH XB DEVICE. THE DEVICE HAD BEEN IMPLANTED ON (B)(6) 2022. DURING A SUBSEQUENT SURGICAL PROCEDURE, THE SURGEON OBSERVED TISSUE ADHESION INVOLVING THE SILICONE-COATED SURFACE OF THE MESH. A PORTION OF THE MESH WAS SURGICALLY EXCISED. THE REMAINING PORTION OF THE DEVICE REMAINED IMPLANTED. NO PATIENT IMPACT. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE REPORTED LOT HAS BEEN INITIATED. NO ADDITIONAL CLINICAL DETAILS HAVE BEEN PROVIDED TO DATE. INVESTIGATION REMAINS ONGOING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 588584 | SURGIMESH XB | MESH, SURGICAL, POLYMERIC | FTL | CHAMBERLAIN TECHNOLOGIES LLC | Z2459227J | 00850011929032 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |