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

Catalog Number	0115320
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	04/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per medical records review, about 6 months post implant of 3dmax mesh, patient was diagnosed with a hernia recurrence.Hernia recurrence is a known inherent risk of surgery.The instructions-for-use supplied with the device list hernia recurrence as a possible complication.To date, this is the only reported complaint for this manufacturing lot.Note, the date of event (15-apr-2017) is considered to be a best estimate.This mdr represents the 3dmax mesh (device #2).An additional supplemental mdr was submitted to represent the 3dmax mesh (device #1).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
Per information provided by patient's attorney: (b)(6) 2016 - patient underwent laparoscopic bilateral inguinal hernia repair with the implant of two 3dmax meshes (device #1 & #2).Per operative notes, ¿sac was dissected completely and repaired with 3dmax meshes." (b)(6) 2017 - patient underwent ultrasound which suggest bilateral indirect inguinal hernia larger on the right side than left.(b)(6) 2017 - patient had pressure on groin without any pain and there was no evidence of hernia.

• 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: 20046305
• Report Number: 1213643-2024-00417
• Device Sequence Number: 7955643
• Product Code: FTL
• UDI-Device Identifier: 00801741030758
• UDI-Public: (01)00801741030758(17)200828(10)HUZH0090
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2024

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: 08/28/2020
• Device Catalogue Number: 0115320
• Device Lot Number: HUZH0090
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 48 YR
• Patient Sex: Male