MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 3DMAX; SURGICAL MESH

Catalog Number	0115312
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Erosion (1750); Necrosis (1971); Obstruction/Occlusion (2422)
Date of Event	08/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was alleged that postoperatively, the patient has experienced mesh erosion, obstruction, necrosis and adhesions thereby underwent removal of mesh.Based on the information provided, no conclusions can be made as to the degree to which the implant may have caused or contributed to the postoperative complications.The adverse reaction section of the instructions-for-use, supplied with the device lists erosion and adhesions as possible complications.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in feb 2023.This mdr represents 3dmax - left (device #1).An another mdr was submitted to represent the 3dmax - right (device #2).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 on (b)(6) 2024 the patient underwent laparoscopic bilateral indirect hernia repair with the implant of two 3dmax mesh (device #1 & device #2).It was reported that the patient experienced abdominal distension, vomiting and intestinal obstruction on (b)(6) 2024 thereby underwent treatments, but there was no improvement.On (b)(6) 2024, patient underwent laparoscopic exploration, during which most of the pelvic fascia was necrotic, left, and right side of the hernia patches were partially eroded and tight adhesions formed an obstruction.The 3dmax mesh was removed and partial small bowel resection, small bowel side anastomosis was performed, and intestinal adhesions were loosened.The patient was transferred to the icu for treatment following the operation.This file represents device #1 (3dmax - left).

• Brand Name: 3DMAX
• 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: 20346458
• Report Number: 1213643-2024-00472
• Device Sequence Number: 8055221
• Product Code: FTL
• UDI-Device Identifier: 00801741030741
• UDI-Public: (01)00801741030741(17)271228(10)HUHN1278
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted 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): 09/17/2024

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: 0115312
• Device Lot Number: HUHN1278
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2023
• 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