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

Catalog Number	0116321
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	04/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, about one year post-implant of 3dmax mid the patient developed right inguinal hernia recurrence and underwent surgical repair.Based on the information available, no conclusions can be made.Recurrence is a known inherent risk of the surgery/use of the device and included as a possible complication in the adverse reaction section of the instructions for use (ifu) supplied with the device.Review of the device history records confirmed the device was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in february, 2021.Not returned - remains implanted.
Event or Problem Description
As reported, during a robotic assisted bilateral inguinal herniorrhaphy procedure on (b)(6) 2021, the patient was implanted with a 3dmax mid large, right and 3dmax mid medium, left.Also performed was the excision of a lipoma in the right groin area.As reported, on (b)(6) 2022 the patient underwent a robotic assisted exploration of the right inguinal area.It was reported that the patient underwent an open repair of recurrent right inguinal hernia with implant of a bard flat mesh on (b)(6) 2022.

• Brand Name: 3DMAX MID
• 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: 14378139
• Report Number: 1213643-2022-00222
• Device Sequence Number: 20247375
• Product Code: FTL
• UDI-Device Identifier: 00801741200786
• UDI-Public: (01)00801741200786
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K200818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/28/2022

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: 12/28/2022
• Device Catalogue Number: 0116321
• Device Lot Number: HUFNAB14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2021
• 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