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

Model Number	0123113
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Inflammation (1932); Pain (1994); Hernia (2240); Disability (2371); Obstruction/Occlusion (2422)
Date of Event	02/23/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
To date, limited information has been provided.Based on the limited information available at this time, we are unable to determine to what extent, if any, the bard device may have caused or contributed to the events as alleged.Recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the ifu as a possible complication.The warning section of the ifu states, "to prevent recurrences when repairing hernias, the prosthesis should be large enough to extend beyond the margins of the defect." if additional information is obtained, a supplemental mdr 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
It is alleged by the patients attorney that on (b)(6) 2008, the patient underwent surgery for repair of an incisional hernia.As reported, a bard/davol composix e/x hernia patch mesh, reference number 0123113, lot number 43bpd262 was implanted to repair the hernia defect.It is alleged that several years later on (b)(6) 2011, the patient underwent an additional surgery to remove the composix e/x, which had failed, and to repair the recurrent incisional hernia.As alleged, the patient was injured severely and permanently and has suffered and will continue to suffer physical pain.
Additional Manufacturer Narrative
To date, limited information has been provided.Based on the limited information available at this time, we are unable to determine to what extent, if any, the bard device may have caused or contributed to the events as alleged.Recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the ifu as a possible complication.The warning section of the ifu states, "to prevent recurrences when repairing hernias, the prosthesis should be large enough to extend beyond the margins of the defect." if additional information is obtained, a supplemental mdr will be submitted.Addendum: h11: this supplemental mdr is submitted to document additional information provided and to correct the manufacturing date.Based on the additional information received, there is no change to the initial determination, no conclusions can be made.Per medical records review, about 2 years post implant of composix e/x, patient was diagnosed with small bowel obstruction, adhesions, inflammation, abscess and hernia recurrence thereby underwent mesh removal.Per the op-notes, ¿edges of the mesh had been rolled¿.The instructions-for-use supplied with the device identify adhesions and inflammation as possible complications.Review of manufacturing records confirms product was manufactured to specification.Updated fields: a2, a4, b4, b5, b6, b7, e3, g1, g3, g6, h2, h6, h10, h11 corrected fields: d1 (brand name), h4 (manufacturing date).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.
Event or Problem Description
It is alleged by the patients attorney that on (b)(6) 2008, the patient underwent surgery for repair of an incisional hernia.As reported, a bard/davol composix e/x hernia patch mesh, reference number (b)(4), lot number 43bpd262 was implanted to repair the hernia defect.It is alleged that several years later on (b)(6) 2011, the patient underwent an additional surgery to remove the composix e/x, which had failed, and to repair the recurrent incisional hernia.As alleged, the patient was injured severely and permanently and has suffered and will continue to suffer physical pain.Addendum per additional information provided: (b)(6) 2008 - patient was diagnosed with incisional hernia thereby underwent open repair with implant of composix e/x.Per the operative notes, "the hernia sac was reduced.The composix e/x mesh was then placed and secured.Polysporin was then placed on the mesh." later a week of implant, patient was hospitalized for 3 days due to abdominal pain, nausea and vomiting.(b)(6) 2009 - patient visited hospital due to bowel obstruction and abdominal pain with cramping.(b)(6) 2011 - patient was diagnosed with small bowel obstruction and recurrent incisional hernia thereby underwent removal of previous mesh.Per the operative notes, "adhesions were taken down between small bowel and the edge of the mesh circumferentially where it had rolled under and created fair amount of adhesions.Scar tissue was completely taken down.We had 5 enterotomies.The old mesh was completely excised." then a piece of biological mesh was placed.Attorney alleges that the patient had abscess, adhesions, hernia recurrence, bowel obstructions, pain, bowel removal and emotional injuries.

• 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: 7080903
• Report Number: 1213643-2017-00967
• Device Sequence Number: 1934065
• Product Code: FTL
• UDI-Device Identifier: 00801741031168
• UDI-Public: (01)00801741031168
• 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: 2008
• Device Explanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2023

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: 02/28/2010
• Device Model Number: 0123113
• Device Catalogue Number: 0123113
• Device Lot Number: 43BPD262
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2017
• Supplement Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 12/04/2017
• Supplement Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2005
• 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: 48 YR
• Patient Sex: Female
• Patient Weight: 91 KG