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

Catalog Number	0112640
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/15/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient underwent an open left inguinal hernia repair procedure on (b)(6) 2011 and was implanted with a bard flat mesh.It was reported that in 2017, the patient contacted the doctor and reported pain at the hernia mesh site.The patient was advised to come into the office for follow-up to have ultrasound and other diagnostic tests.The patient did not comply.In 2019 the patient called the doctor¿s office with the same complaint but, again, did not schedule a follow-up appointment or testing.As reported by the doctor¿s office the patient does not have a scheduled appointment at this time.
Additional Manufacturer Narrative
As reported in 2017, approximately six years post-implant of a bard flat mesh, the patient reported pain in the area of the repair.The patient has reported this symptom to the doctor and was advised to schedule an appointment to be evaluated.At this time the patient has not scheduled an appointment with the doctor.Based on the information available, no conclusions can be made.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in march, 2011.Note; the date of event is considered to be a best estimate as (b)(6) 2017 based on the reported event.Should additional information be provided, a supplemental mdr will be submitted.Not returned.

• 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: 12827883
• Report Number: 1213643-2021-20423
• Device Sequence Number: 11143133
• Product Code: FTL
• UDI-Device Identifier: 00801741016493
• UDI-Public: (01)00801741016493
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/09/2021

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: 03/28/2016
• Device Catalogue Number: 0112640
• Device Lot Number: HUVB2154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2011
• 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: 34 YR
• Patient Sex: Male