MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. COMPOSIX MESH E/X; SURGICAL MESH

Catalog Number	0123790
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Hernia (2240); Disability (2371)
Date of Event	06/22/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided we are unable to determine to what extent, if any the bard device may have caused or contributed to the events as alleged by the patient¿s attorney.The information provided alleges that the patient underwent an additional surgery to "remove mesh and recurrence repair." the patient's attorney did not allege a specific device failure or reason for explant and no medical records have been provided.Recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication.Should additional information be provided a supplemental emdr will be submitted.The information provided by bard 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 bard.Not returned.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2011: the patient underwent surgery for repair of a ventral hernia.A bard/davol composix e/x hernia patch mesh, (b)(4), lot number huud1833 was implanted to repair the hernia defect.(b)(6) 2012: the patient underwent an additional surgery to remove mesh and recurrence repair.As alleged, the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the alleged defective composix e/x hernia patch.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2011: the patient underwent surgery for repair of a ventral hernia.A bard/davol composix e/x hernia patch mesh, reference number (b)(4), lot number huud1833 was implanted to repair the hernia defect.(b)(6) 2012: the patient underwent an additional surgery to remove mesh and recurrence repair.As alleged, the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the alleged defective composix e/x hernia patch.Addendum per additional information provided: (b)(6) 2011 - patient was diagnosed with symptomatic ventral hernia thereby underwent open repair with the implant of composix mesh e/x.Per operative notes, ¿the hernia sac was opened.There were some omental adhesions, and it was taken down.A composix mesh e/x was placed intraabdominally and sutured.¿ (b)(6) 2012 - patient was diagnosed with recurrent massive incisional hernia thereby underwent open repair with explant of composix e/x mesh.Per operative notes, ¿there was a small piece of mesh which was removed.While removing, it was firmly adherent to a small bowel loop, so the small bowel resection was performed.An onlay biologic mesh, two pieces were sewn together and placed over the defect using sutures.¿ attorney alleges that the patient had mesh migration, mesh shrinkage, nerve damage, pain, hernia recurrence, removal surgery and emotional injuries.
Additional Manufacturer Narrative
Based on the information provided we are unable to determine to what extent, if any the bard device may have caused or contributed to the events as alleged by the patient¿s attorney.The information provided alleges that the patient underwent an additional surgery to "remove mesh and recurrence repair." the patient's attorney did not allege a specific device failure or reason for explant and no medical records have been provided.Recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct manufacturing date.Based on the additional information received, there is no change to initial determination, no conclusions can be made.Per medical records review, about 1 year 3 months post implant of composix mesh e/x, patient was diagnosed with hernia recurrence thereby underwent repair with mesh removal.A review of the manufacturing records was performed and found that the lot was manufactured to specification.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: not returned.

• Brand Name: COMPOSIX MESH E/X
• 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: 7285122
• Report Number: 1213643-2018-00331
• Device Sequence Number: 1044747
• Product Code: FTL
• UDI-Device Identifier: 00801741031205
• UDI-Public: (01)00801741031205(17)150528(10)HUUD1833
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K002684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

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: 05/28/2015
• Device Catalogue Number: 0123790
• Device Lot Number: HUUD1833
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2010
• 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: Disability; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male