MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 COMPOSIX MESH E/X; SURGICAL MESH

Catalog Number	0123790
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Injury (2348); Obstruction/Occlusion (2422)
Date of Event	07/07/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made to what extent the bard/davol composix e/xmay have caused or contributed to the reported event.The cause of the patient postoperative complications cannot be determined at this time.The patient's attorney alleges subsequent surgical intervention; however, no details have been provided.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.Should additional information be provided a supplemental emdr will be submitted.Device evaluated by mfr? not returned.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2007: the patient underwent surgery for implant of an unspecified bard/davol composix e/x.On ni/ni/ni: the patient had subsequent surgical intervention due to the hernia mesh device(s).The patient is making a claim for an adverse patient outcome against the bard/davol composix e/x.The attorney alleges patient experienced emotional distress and the device was defective.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2007: the patient underwent surgery for implant of an unspecified bard/davol composix e/x.(b)(6): the patient had subsequent surgical intervention due to the hernia mesh device(s).The patient is making a claim for an adverse patient outcome against the bard/davol composix e/x.The attorney alleges patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2007 - patient was diagnosed with umbilical/ventral hernia thereby underwent laparoscopic repair with implant of composix e/x mesh.Per operative notes, ¿a large hernia defect was identified and removed.A composix e/x mesh was placed and tacked.¿ (b)(6) 2011 - patient was diagnosed with small bowel obstruction and adhesions thereby underwent open repair with lysis of adhesions.Per operative notes, ¿the omental adhesions were taken down.There were two loops of small bowel adherent to prior mesh was taken down.The loops of bowel causing obstruction were released.All the adhesions of mesh were taken down and sutured.¿.
Additional Manufacturer Narrative
At this time no conclusions can be made to what extent the bard/davol composix e/xmay have caused or contributed to the reported event.The cause of the patient postoperative complications cannot be determined at this time.The patient's attorney alleges subsequent surgical intervention; however, no details have been provided.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.Addendum: this supplemental emdr is submitted to document additional information provided.Root cause is inconclusive; no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.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: COMPOSIX MESH E/X
• 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 ; 4018258495
• MDR Report Key: 8351451
• Report Number: 1213643-2019-00944
• Device Sequence Number: 2137662
• Product Code: FTL
• UDI-Device Identifier: 00801741031205
• UDI-Public: (01)00801741031205(10)43AQD785
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K002684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2025

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 Catalogue Number: 0123790
• Device Lot Number: 43AQD785
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 02/19/2019
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 117 KG