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); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Abdominal Pain (1685); Adhesion(s) (1695); Erythema (1840); Fistula (1862); Hernia (2240)
Date of Event	08/27/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per medical records review, about 3 years post implant of composix l/p mesh, patient was diagnosed with hernia recurrence, adhesions, fistula, erythema, abdominal pain and wound dehiscence thereby underwent repair with removal of mesh.The instructions-for-use supplied with the device lists hernia recurrence, fistula and adhesions as possible complications.A review of the manufacturing records was performed and found that the lot was manufactured to specification.This emdr represents the mesh ¿ composix l/p (device #2).An additional supplemental emdr was submitted to represent the mesh ¿ ventralex (device #1).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
Per information provided by patient's attorney: (b)(6) 2006 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with the implant of ventralex mesh (device #1).Per operative notes, ¿hernia recurrence was noted, and sac was excised.Adhesions were taken down.A large umbilical ventralex mesh (device #1) was used and sutured.¿.(b)(6) 2009 - patient was diagnosed with incarcerated recurrent incisional hernia and abdominal pain thereby underwent open repair with removal of ventralex mesh (device #1) and implant of composix l/p mesh (device #2).Per operative notes, ¿the hernia was very scarred and the bowel freed from the hernia sac.The ventraiex mesh (device #1) was adherent at the superior aspect of the wound and the mesh was removed.A composix l/p mesh (device #2) was placed into the abdominal wall and sutured.¿.(b)(6) 2012 - patient presents with abdominal pain.(b)(6) 2012 - patient was diagnosed with recurrent incisional hernia, enterocutaneous fistula and erythema with some wound drainage thereby underwent open repair with removal of composix l/p mesh (device #2) and small bowel resection.Per operative notes, ¿the mesh was encountered and noted dense adhesive disease of the small bowel to the mesh and to the abdominal wall.Small bowel resection was carried out.The entire composix l/p mesh (device #2) was removed.¿.Attorney alleges that the patient had adhesions, bowel/intestinal obstruction, bowel/intestinal removal, infection, pain and hernia recurrence.

• 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: 19059370
• Report Number: 1213643-2024-091825
• Device Sequence Number: 20298314
• 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: 2009
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/08/2024

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: 12/28/2013
• Device Catalogue Number: 0134450
• Device Lot Number: HUSK1405
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2008
• 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: 55 YR
• Patient Sex: Female
• Patient Weight: 91 KG