MAUDE Adverse Event Report: Davol Inc., Sub. C.R. Bard, Inc. -1213643 Mesh - Composix E/X; Surgical Mesh

Catalog Number	0123680
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); Insufficient Information (4580)
Date of Event	07/08/2020
Type of Reportable Event	Serious Injury
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 experienced emotional distress and the device was defective.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "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 experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2007 - patient was diagnosed with recurrent incarcerated incisional ventral hernia and umbilical hernia thereby underwent laparoscopic repair with implant of composix e/x mesh.Per op notes, ¿adhesions were identified at the omentum to the lower midline.An umbilical hernia was identified.The upper abdominal hernia was behind the falx, the falx was divided and was taken down.The incarcerated recurrent incisional ventral hernia was identified.A composix e/x mesh was placed into the abdominal cavity and tacked to the anterior abdominal wall using staplers.¿ (b)(6) 2020- patient was diagnosed with asia syndrome secondary to hernia mesh thereby underwent open repair with the removal of mesh.Per op notes, ¿a vertical skin incision was created, and the linea alba was incised.The composix e/x mesh was identified posteriorly.The abdominal wall including intact transversalis fascia was dissected off the mesh.The perimeter of the composix e/x mesh of the was dissected away from the anterior abdominal wall.There adhesions of the greater omentum to the undersurface of the previous composix e/x mesh were taken down.The previously placed composix e/x mesh was excised and the linea alba was closed with sutures.¿.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "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: 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.Updated fields: a2, a4, b2, b3, b4, b5, b7, d1, d3, d4 (product lot no., product catalog no., udi no), d.6b (date of explant), g3, g6, h2, h6, h10.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: 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 ; +1(401)825-8495
• MDR Report Key: 14515098
• Report Number: 1213643-2022-94132
• Device Sequence Number: 5628879
• Product Code: FTL
• UDI-Device Identifier: 00801741031199
• UDI-Public: (01)00801741031199(10)43JQD309
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2026

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: 0123680
• Device Lot Number: 43JQD309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2022
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 08/24/2026
• 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 Sex: Female
• Patient Weight: 97 LB