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

Catalog Number	0134450
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	11/09/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided by patient's attorney: (b)(6) 2013 - patient was diagnosed with symptomatic ventral hernia thereby underwent laparoscopic repair with implant of composix l/p mesh (device #1).Per operative notes, "lysis of adhesions was required and the defect was identified.A composix l/p mesh (device #1) was placed through the middle of the defect and secured.¿ (b)(6) 2013 - patient was diagnosed with symptomatic recurrent ventral hernia thereby underwent laparoscopic repair with implant of composix l/p mesh (device #2).Per operative notes, "dense adhesions noted to the previously placed mesh were lysed.A composix l/p mesh (device #2) was secured into the peritoneal cavity, brought out through the defect with suture and secured." (b)(6) 2014 - patient was diagnosed with recurrent ventral hernia thereby underwent open repair with implant of sepramesh ip (device #3).Per operative notes, "hernia defect was easily reduced.A small section of sepramesh ip (device #3) was secured into the peritoneal cavity, sewn circumferentially into the defect and sutured." (b)(6) 2015 - patient was diagnosed with ventral & left inguinal hernia thereby underwent repair with mesh removal (device #1, #2 & #3).Per operative notes, "the old mesh (device #1, #2 & #3) had retracted and was noted to be in a ball.This was excised.Limited lysis of adhesions was required.A prolene mesh was secured with sutures." attorney alleges that the patient had adhesions, hernia recurrence, infection, excised abdominal wall sinus, extensive scar tissues, excision of mesh and emotional injuries.
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per medical records review, about 2 years 9 months post implant of composix l/p mesh, patient was diagnosed with adhesions, hernia recurrence and material deformation thereby underwent repair with mesh removal.Per operative notes, "the old mesh had retracted and was noted to be in a ball.This was excised." the instructions-for-use (ifu) supplied with the device identify hernia recurrence and adhesions as possible complications.This emdr represents mesh ¿ composix l/p (device #1).An additional emdr was submitted to represent mesh ¿ composix l/p (device #2) and a supplemental emdr was submitted to represent sepramesh ip (device #3).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 L/P
• Common Device Name: SURGICAL 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: 18892818
• Report Number: 1213643-2024-091108
• Device Sequence Number: 7588933
• Product Code: FTL
• UDI-Device Identifier: 00801741031267
• UDI-Public: (01)00801741031267
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K061754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2024

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: 08/28/2017
• Device Catalogue Number: 0134450
• Device Lot Number: HUWH0939
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 03/13/2024
• 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: 54 YR
• Patient Sex: Male
• Patient Weight: 118 KG