MAUDE Adverse Event Report: CHAMBERLAIN TECHNOLOGIES LLC SURGIMESH XB; MESH, SURGICAL, POLYMERIC

Catalog Number	TINTRA R-1415
Medical Device Problem Code	Adhesive Too Strong (4071)
Health Effect - Clinical Code	Abdominal Pain (1685)
Type of Reportable Event	Serious Injury
Event or Problem Description
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.

• Brand Name: SURGIMESH XB
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): CHAMBERLAIN TECHNOLOGIES LLC; 21805 w field pkwy suite 160; deer park IL 60010
• Manufacturer (Section G): MEDICAL MURRAY; 540 capital drive; lake zurich 60047
• Manufacturer Contact: john huelskamp ; 21805 w. field pkwy suite 160; deer park, IL 60010 ; 8473769784
• MDR Report Key: 24527651
• Report Number: 3015860534-2026-00001
• Device Sequence Number: 12890494
• Product Code: FTL
• UDI-Device Identifier: 00850011929032
• UDI-Public: 00850011929032
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K072974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 01/01/2024
• Device Catalogue Number: TINTRA R-1415
• Device Lot Number: Z2459227J
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown