MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. MESH ¿ COMPOSIX L/P; SURGIAL MESH

Catalog Number	0134810
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Ischemia (1942); Strangulation (2084); Hernia (2240); Injury (2348); Obstruction/Occlusion (2422)
Date of Event	12/28/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges surgical intervention; however, no details have been provided.No lot number has been provided; therefore a review of the manufacturing records is not possible.Should additional information be provided a supplemental emdr will be submitted.Not returned.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2010: the patient underwent surgery for implant of a bard/davol composix mesh.Ni/ni/ni: the patient underwent additional surgical intervention.The patient's attorney alleges patient experienced emotional distress due to the defective device.
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges surgical intervention; however, no details have been provided.No lot number has been provided; therefore a review of the manufacturing records is not possible.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct the brand name.Based on the additional information received, there is no change to initial determination, no conclusions can be made.Per medical records review, about 5 years 7 months post implant of composix l/p mesh, patient was diagnosed with strangulation, hernia, obstruction and ischemia thereby underwent repair with removal of mesh.The instructions-for-use supplied with the device list hernia recurrence as a possible complication.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Note, the manufacturing date (15-oct-2009) is considered to be a best estimate.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.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6)2010: the patient underwent surgery for implant of a bard/davol composix mesh.(b)(6): the patient underwent additional surgical intervention.The patient's attorney alleges patient experienced emotional distress due to the defective device.Addendum per additional information: (b)(6)2010 - patient was diagnosed with incarcerated incisional hernia thereby underwent open repair with the implant of composix l/p mesh.Per operative notes, ¿the defect was identified and omentum in defect was dissected.A piece of composix l/p mesh was sutured into fascial margins using sutures.¿ (b)(6)2015 - patient had abdominal pain was diagnosed with recurrent incarcerated strangulated ventral hernia and ischemia thereby underwent laparoscopic converted to open repair with the removal of mesh.Per operative notes, ¿the hernia was reduced.There was evidence of ischemic small bowel was resolved by release of the incarcerated small intestine from the hernia and deserosalization of small intestine was repaired with sutures.The previous mesh was removed, and a biologic mesh was sutured circumferentially into wound defect.¿ attorney alleges that the patient had adhesions, bowel obstruction, bowel perforation, pain and suffering.

• Brand Name: MESH ¿ COMPOSIX L/P
• Common Device Name: SURGIAL 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: 8237470
• Report Number: 1213643-2019-00166
• Device Sequence Number: 1910497
• Product Code: FTL
• UDI-Device Identifier: 00801741031311
• UDI-Public: (01)00801741031311(17)150228(10)HUTJ0741
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K061754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2025

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: 02/28/2015
• Device Catalogue Number: 0134810
• Device Lot Number: HUTJ0741
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2018
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2009
• 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; Life Threatening
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 129 KG