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

Catalog Number	0112720
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hematoma (1884); Hypersensitivity/Allergic reaction (1907)
Date of Event	08/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, patient had possible allergic reaction and hematoma post implant of flat mesh.The patient's allergist has been provided with a sample mesh to perform reactivity testing.As reported, the testing has not been scheduled.Based on the information provided to date, no conclusion can be made.If/when reactivity test results are provided, a supplemental mdr will be submitted.The adverse reactions section of the instructions-for-use, supplied with the device lists hematoma as a possible complication.To date, this is the only reported complaint for this manufacturing lot.Note, the date of event ((b)(6) 2023) and date of implant ((b)(6) 2007) are provided as a best estimate.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, patient with history of breast cancer, underwent breast reconstruction procedure which grafting from her abdominal wall was involved.In 2007 patient underwent an abdominal wall reconstruction procedure using a flat mesh for support.It was reported that about 2 years ago, patient started to notice a hardened area along the incision line and was told it was a possible hematoma and the area never resolved.As reported, in (b)(6) 2023, the surgeon performed an exploratory procedure and noted a small pocket of blood.Patient reported of having three more blood filled areas along her abdominal wall that have erupted.It was reported that surgeon would like to perform a reactivity test with a sample of the mesh prior to possibly removing the entire piece of mesh from the patient.

• Brand Name: BARD FLAT MESH
• 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: 19189019
• Report Number: 1213643-2024-00158
• Device Sequence Number: 15573500
• Product Code: FTL
• UDI-Device Identifier: 00801741016561
• UDI-Public: (01)00801741016561
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/08/2024

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: 0112720
• Device Lot Number: 43BOD055
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Female