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

Catalog Number	0112700
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hernia (2240); Fluid Discharge (2686); Neuralgia (4413); Swelling/ Edema (4577)
Date of Event	11/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, post implant of pre-shaped mesh the patient had swelling, fluid discharge, nerve pain and was subsequently diagnosed with a recurrent hernia.The information provided does not help to determine root cause for the patient¿s postoperative course.No conclusions can be made as to the degree to which the implant may have caused or contributed to the patient¿s postoperative symptoms/diagnosis.The adverse reactions section of the instructions-for-use, supplied with the device identifies hernia recurrence as a possible complication.Review of manufacturing records shows product was made to specification.To date, this is the only reported complaint for this manufacturing lot of 102 units released for distribution in february 2021.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3.
Event or Problem Description
As reported, the patient underwent an open left inguinal hernia repair on (b)(6) 2022.About 3 weeks post op the patient had significant swelling in the left groin, and testicle.He followed up with the surgeon who drained some fluid from the surgical site, cleaned out the area and reclosed the incision using a glue.As reported, the patient has experienced nerve pain ever since.The patient was subsequently diagnosed with a recurrent hernia and was told he will need another surgery.The revision procedure has not yet been scheduled.

• Brand Name: BARD MESH PRE-SHAPED
• 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: 19087718
• Report Number: 1213643-2024-00144
• Device Sequence Number: 15229491
• Product Code: FTL
• UDI-Device Identifier: 00801741016547
• UDI-Public: (01)00801741016547
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/27/2024

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: 12/28/2025
• Device Catalogue Number: 0112700
• Device Lot Number: HUFN0317
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2021
• 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: 54 YR
• Patient Sex: Male