MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 BARD MESH PRE-SHAPED W/ KEYHOLE; SURGICAL MESH

Catalog Number	0113710
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Erythema (1840)
Date of Event	02/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, during laparoscopic left inguinal hernia repair procedure, the patient was implanted with pre-shaped mesh w/ keyhole on (b)(6) 2023.It was reported that 5 days post-implant of the mesh, the patient developed local redness and stiffness of the wound.It was also reported that the patient symptoms have been treated by local hot compress and physiotherapy.The patient is reported to be in good condition.
Additional Manufacturer Narrative
Based on the information available, no conclusions can be made.The patient is currently reported to be in good condition, following treatment.A review of the manufacturing records finds the lot was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in october 2021.Not returned - remains implanted.

• Brand Name: BARD MESH PRE-SHAPED W/ KEYHOLE
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 17001293
• Report Number: 1213643-2023-00209
• Device Sequence Number: 17934205
• Product Code: FTL
• UDI-Device Identifier: 00801741030703
• UDI-Public: (01)00801741030703
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/10/2023

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: 08/28/2026
• Device Catalogue Number: 0113710
• Device Lot Number: HUFW0897
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2021
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male