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

Catalog Number	0123810
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Unspecified Infection (1930); Hernia (2240); Bowel Perforation (2668)
Date of Event	12/07/2007
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 emdr represent the composix ex mesh (device #2).An additional supplemental emdr was submitted to represents the bard flat mesh (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: on (b)(6) 2002: patient was diagnosed with recurrent incisional hernia thereby underwent open repair with implant of bard flat mesh (device#1).Per operative notes, ¿the old synthetic mesh (goretex) and adhesions were removed.A bard flat mesh (device#1) was placed and secured by sutures.¿ on (b)(6) 2007: patient was diagnosed with recurrent ventral hernia thereby underwent laparoscopic repair with partial explant of bard flat mesh (device #1) and implant of composix ex mesh (device#2).Per operative notes, ¿loops of bowel adhered into the previous mesh (device#1) were excised.Adhesions removed.A composix ex mesh (device#2) placed intra-abdominally and tacked.¿ on (b)(6) 2007: patient was diagnosed with small perforation in mid-transverse colon thereby underwent laparoscopic repair with explant of composix ex mesh (device#2).Per operative notes, ¿the transverse colon was densely adhered to the previous (device#1).Infected-smelling opaque fluid and adhesions noted.Then (device#2) removed along with staples.¿ on (b)(6) 2009: patient was diagnosed with recurrent ventral hernia thereby underwent open repair with explant of mesh (device#1 & #2) & implant of synthetic mesh (permacol).Per operative notes, ¿adhesions were noted.Both pieces of mesh (device#1 & #2) were removed.A synthetic mesh (permacol) was placed and secured by sutures.

• Brand Name: COMPOSIX MESH 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: 21975211
• Report Number: 1213643-2025-090203
• Device Sequence Number: 20639831
• Product Code: FTL
• UDI-Device Identifier: 00801741031212
• UDI-Public: (01)00801741031212
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 2009
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2025

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
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 05/07/2025
• 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; Disability; Life Threatening
• Patient Age: 55 YR
• Patient Sex: Female