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

Catalog Number	0113700
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient developed an infection at the incision site post implant of pre-shaped mesh.Based on the information provided, no conclusion can be made as to the degree to which the device may have caused or contributed to the patient¿s postoperative course.Postoperative infection is known inherent risk of surgery/use of the device.The warnings section in instructions-for-use, supplied with the device states, "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the device." review of manufacturing records shows product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of(b)(6) units released for distribution in december 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.
Event or Problem Description
As reported, the patient underwent tension-free repair procedure of unilateral inguinal hernia with implant of pre-shaped mesh on (b)(6) 2024.It was reported that patient developed infection at the incision two days later and was immediately given incisional drainage and anti-infective treatment was provided with medications.It was reported that patient was discharged on (b)(6) 2024 with improvement in health status.

• 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: 19264506
• Report Number: 1213643-2024-00240
• Device Sequence Number: 14098844
• Product Code: FTL
• UDI-Device Identifier: 00801741030697
• UDI-Public: (01)00801741030697
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/17/2024

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 Catalogue Number: 0113700
• Device Lot Number: HUFX2243
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2021
• 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 Sex: Unknown