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

Catalog Number	0117011
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	12/09/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per the medical records review, about 6 months post implant of bard soft mesh, patient was diagnosed with hernia recurrence thereby underwent repair.The instructions-for-use supplied with the device list hernia recurrence as a possible complication.This emdr represents the bard soft mesh (device #1).An additional supplemental emdrs were submitted to represent the bard mesh pre-shaped w/ keyhole (device #2) and perfix plug (device #3).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.H3 other text : device not returned.
Event or Problem Description
Per information provided by patient's attorney: (b)(6) 2015 - patient was diagnosed with right inguinal hernia thereby underwent laparoscopic repair with the implant of bard soft mesh (device #1) on (b)(6) 2015.Per operative notes, ¿the peritoneal contents off the cord structures at the level of the umbilicus were dissected.A piece of bard soft mesh (device #1) was placed centered on the internal ring, tucked down under the peritoneum inferiorly.¿ (b)(6) 2015 - patient was diagnosed with recurrent right inguinal hernia thereby underwent open repair with the implant of bard mesh pre-shaped w/ keyhole (device #2) and perfix plug (device #3).Per operative notes, ¿an indirect hernia sac was identified.A extra-large perfix plug (device #3) was fixed to the undersurface of the deformed abdominal wall and the "shutter" of the internal oblique.A bard preshaped w/ keyhole patch (device #2) was placed and then fixed to the fascia of the inguinal floor, at the pubis, along the shelving edge.¿ (note, there was no mention/visualization of device #1 during the repair).Attorney alleges that the patient had adhesions, bowel obstruction, pain, hernia recurrence and emotional injuries.
Event or Problem Description
Per information provided by patient's attorney: on (b)(6) 2015 - patient was diagnosed with right inguinal hernia thereby underwent laparoscopic repair with the implant of bard soft mesh (device #1) on (b)(6) 2015.Per operative notes, ¿the peritoneal contents off the cord structures at the level of the umbilicus were dissected.A piece of bard soft mesh (device #1) was placed centered on the internal ring, tucked down under the peritoneum inferiorly.¿ on (b)(6) 2015 - patient was diagnosed with recurrent right inguinal hernia thereby underwent open repair with the implant of bard mesh pre-shaped w/ keyhole (device #2) and perfix plug (device #3).Per operative notes, ¿an indirect hernia sac was identified.A extra-large perfix plug (device #3) was fixed to the undersurface of the deformed abdominal wall and the "shutter" of the internal oblique.A bard preshaped w/ keyhole patch (device #2) was placed and then fixed to the fascia of the inguinal floor, at the pubis, along the shelving edge.¿ (note, there was no mention/visualization of device #1 during the repair) attorney alleges that the patient had adhesions, bowel obstruction, pain, hernia recurrence and emotional injuries.
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per the medical records review, about 6 months post implant of bard soft mesh, patient was diagnosed with hernia recurrence thereby underwent repair.The instructions-for-use supplied with the device list hernia recurrence as a possible complication.Addendum #1: h11: this supplemental emdr is submitted to correct the expiry date.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Corrected field: d4 (expiry date).This supplemental emdr represents the bard soft mesh (device #1).An additional supplemental emdrs were submitted to represent the bard mesh pre-shaped w/ keyhole (device #2) and perfix plug (device #3).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.

• Brand Name: BARD SOFT MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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 ; 4018258495
• MDR Report Key: 18354281
• Report Number: 1213643-2023-095246
• Device Sequence Number: 12456272
• Product Code: FTL
• UDI-Device Identifier: 00801741030888
• UDI-Public: (01)00801741030888
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2024

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: 07/28/2019
• Device Catalogue Number: 0117011
• Device Lot Number: HUYF1813
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2023
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2014
• 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: 79 YR
• Patient Sex: Male