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

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Chamberlain technologies was notified by medical murray, approved contract manufacturer, that mdr report (mw5115459) was received by the fda on 23-mar-2023 for a potential adverse event reported by a healthcare facility to the fda on 01-mar-2023.Per mdr report, a serious injury was reported on (b)(6) 2023 (incident date) where a surgimesh (lot # z2459018c) placed in 2021 was explanted on (b)(6) 2023.Initial reporter (nurse) reported an unspecified infection (1930); use of device problem (1930).The device was not returned for evaluation.An event history review was performed for the lot # (z2459018c) where the lot history record (lhr) record was reviewed and determined that the lot was manufactured per specification.In addition, a review of complaints for specific catalog number (tintra ok-1522) concluded that no other events or complaints have been reported for this lot (z2459018c).Investigation findings is no device problem found (213), cause not established (4315).If additional information is received, it will be evaluated to determine if a follow-up report is required.
Event or Problem Description
An mdr report # mw5115459 was received by supplier/manufacturing partner medical murray from fda, and submitted to chamberlain technologies' distributor (b)(4) on 23-mar-2023.The description of the mdr stated "surgimesh placed on (b)(6) 2021, infection identified (b)(6) 2021.1 year treatment with infectious disease, surgeon, antibiotic therapy.Meshed was removed (b)(6) 2023.Ct(computed tomography) abdomen: large abdominal wall fluid collection underlying the surgical mesh.Measuring 5.9 x 10.2 approximately.Drain placed" mesh was explanted on (b)(6) 2023.

• Brand Name: SURGIMESH XB
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): CHAMBERLAIN TECHNOLOGIES; 21805 w.field pkwy; suite 160; deer park IL 60010
• Manufacturer (Section G): MEDICAL MURRAY; 540 capital dr.; lake zurich IL 60047
• Manufacturer Contact: john huelskamp ; 21805 w.field pkwy; suite 160; deer park, IL 60010 ; 8473044069
• MDR Report Key: 16789201
• Report Number: 3015860534-2023-00001
• Device Sequence Number: 5522528
• Product Code: FTL
• UDI-Device Identifier: 00850011929124
• UDI-Public: 00850011929124
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/20/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2023
• Device Model Number: N/A
• Device Catalogue Number: TINTRA OK-1522
• Device Lot Number: Z2459018C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2020
• 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
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown