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

Catalog Number	0123810
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240); Obstruction/Occlusion (2422); Insufficient Information (4580)
Date of Event	10/25/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges that the patient had subsequent surgical intervention and "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient"; 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
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol composix e/x on (b)(6) 2007.As reported, the patient is making a claim for an adverse patient outcome against the composix e/x.Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is also alleged that the patient underwent revision surgery on (b)(6) 2012.It is also alleged that the patient experienced emotional distress and the device was defective.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges that the patient had subsequent surgical intervention and "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient"; 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 to correct date of event.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.Updated fields: a2, b2, b4, b5, b6, b7, d4, (product catalog no, corporate lot no, udi no), d.6b (date of explant), g3, g6, h2, h6, h10, h11.Corrected filed: b3 (date of event).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
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol composix e/x on (b)(6) 2007.As reported, the patient is making a claim for an adverse patient outcome against the composix e/x.Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is also alleged that the patient underwent revision surgery on (b)(6) 2012.It is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2007 ¿ patient was diagnosed with incarcerated ventral hernia thereby underwent open repair with the implant of composix e/x mesh (device #1).Per op notes, ¿there was a bridge of mesh previously placed between the two fascial defects.The incarcerated omentum which was adherent to the hernia sac was excised.A bard composix e/x mesh (device #1) was placed in the peritoneum and secured sublay using sutures.¿ (b)(6) 2012 - patient was diagnosed with small bowel obstruction secondary to adhesions thereby underwent open repair.Per op notes, ¿the entire mesh was covered with adhesions to the bowel.There was one loop on the left side of the mesh was densely adherent was scrapped off.¿ (b)(6) 2013 ¿ patient was diagnosed with small bowel obstruction secondary to incarcerated recurrent incisional ventral hernia and adhesions thereby underwent open repair with the removal of mesh (device #1) and implant of xenmatrix mesh (device #2).Per op notes, ¿a very dilated small bowel was found.Patient had a bridge of old mesh (device #1) between the upper defect and the lower defect were removed and the mesh was divided.There were extensive adhesions between loops of bowel in between the bowel and the anterior abdominal wall and the hernia sacs which were divided.Then, onlay xenmatrix mesh (device #2) was placed into defect and secured using sutures.¿ (b)(6) 2018 ¿ patient was diagnosed with abdominal wall abscess with infected mesh thereby underwent laparoscopic repair with the removal of mesh (device #2).Per op notes, ¿the patient have extensive omental adhesions to the intra-abdominal wall and loop of small bowel to the right side of the mesh.The seroma with purulent fluid was aspirated transabdominally.The mesh was then removed from the abdominal wall.Cholecystectomy were done.¿.

• Brand Name: MESH - COMPOSIX 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: 12101421
• Report Number: 1213643-2021-05465
• Device Sequence Number: 17186033
• Product Code: FTL
• UDI-Device Identifier: 00801741031212
• UDI-Public: (01)00801741031212
• 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: 2007
• Device Explanted Year: 2013
• 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: 0123810
• Device Lot Number: 43KQD320
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 07/01/2021
• 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: Disability; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female