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

Catalog Number	0134810
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Unspecified Infection (1930); Hernia (2240); Insufficient Information (4580)
Date of Event	05/25/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient.The patient's attorney alleges that the patient had 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.This emdr represents the bard/davol mesh - composix l/p (device #2).Additional emdrs were submitted to represent the bard/davol mesh - composix l/p (device #1) and the bard/davol mesh - ventralex (device #3).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 unspecified bard/davol composix l/p (x2) on (b)(6) 2007 and ventralex hernia patch on (b)(6) 2011.As reported, the patient is making a claim for an adverse patient outcome against all devices.Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device.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 adverse patient outcome associated with the hernia mesh used to treat the patient.The patient's attorney alleges that the patient had 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.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.This supplemental emdr represents the bard/davol mesh ¿ composix l/p (device #2).Additional supplemental emdr was submitted to represent the bard/davol mesh ¿ composix l/p (device #1); an additional emdr was submitted to represent the bard/davol mesh ¿ dulex (device #3) & an additional supplemental emdr was submitted to represent the bard/davol mesh ¿ ventralex (device #4).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 unspecified bard/davol composix l/p (x2) on (b)(6) 2007 and ventralex hernia patch on (b)(6) 2011.As reported, the patient is making a claim for an adverse patient outcome against all devices.Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device.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 incisional hernia thereby underwent laparoscopic repair with the implant of two composix l/p (device #1 & #2).Per op notes, ¿two composix l/p mesh (device #1 & #2) were placed within the abdomen and tacked to the left aspect of the hernia using sutures.¿ (b)(6) 2009 - patient was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with the implant of dulex mesh (device #3).Per op notes, ¿omental adhesions were taken down.A dulex mesh (device #3) was placed in the abdomen and tacked to the overlying peritoneum using sutures.¿ (note: there is no mention/visualization of previously placed composix l/p (device #1 & #2) during this repair) (b)(6) 2011 - patient was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with the implant of ventralex mesh (device #4).Per op notes, ¿a small defect was noted in the left lower quadrant where two previous placed meshes (device #1 & #2) come together.A ventralex mesh (device #4) was placed in the abdomen and tacked over to overlie the defect.¿ (note: there is no mention/visualization of previously placed dulex mesh (device #3) during this repair) (b)(6) 2012 - patient was diagnosed with infected mesh from incisional hernia thereby underwent repair with removal of mesh (device #1, #2, #3 & #4).Per op notes, ¿the abdomen was entered, and a large piece of mesh was encountered and an extensive adhesiolysis was performed.The mesh (device #1, #2, #3 & #4) was then removed.There was noted to be an abscess cavity in the lateral left aspect of the mesh.¿.

• Brand Name: MESH ¿ COMPOSIX L/P
• 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: 11920958
• Report Number: 1213643-2021-04197
• Device Sequence Number: 845466
• Product Code: FTL
• UDI-Device Identifier: 00801741031311
• UDI-Public: (01)00801741031311(17)111028(10)DAQJ0020
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K061754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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: 10/28/2011
• Device Catalogue Number: 0134810
• Device Lot Number: DAQJ0020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 05/14/2025
• 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: 49 YR
• Patient Sex: Female