MAUDE Adverse Event Report: MEDICAL MURRAY, INC. SURGIMESH XB BG MEDICAL; MESH, SURGICAL, POLYMERIC

Lot Number Z2459D18C

Device Problem Use of Device Problem (1670)

Patient Problem Unspecified Infection (1930)

Event Date 02/21/2023

Event Type  Injury  

Event Description

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.

• Brand Name: SURGIMESH XB BG MEDICAL
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): MEDICAL MURRAY, INC.
• MDR Report Key: 16489024
• MDR Text Key: 310860229
• Report Number: MW5115459
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 07/01/2023
• Device Lot Number: Z2459D18C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 108 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White