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

Catalog Number	0134450
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Hernia (2240)
Date of Event	10/21/2011
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6)2008 - patient was diagnosed with recurrent umbilical hernia thereby underwent open repair with implant of ventralex mesh (device 1).Per operative notes, "a semicircular incision was made in the skin superior to the umbilicus.The hernia sac was identified and was dissected free from the deep tissue.A ventralex mesh (device 1) was placed into the abdominal fascia in a tension free repair and secured it with sutures." (b)(6)2011 - patient was diagnosed with recurrent incarcerated umbilical hernia, adhesion thereby underwent laparoscopic repair with implant of composix lp mesh (device 2) and explant of ventralex mesh (device 1).Per operative notes, "an incision was made around the umbilicus.The hernia sac was dissected out.There were multiple adhesions to the abdominal wall around the previous ventralex mesh (device 1).Extensive lysis of adhesions was performed.The ventralex mesh (device 1) was excised entirely.A composix lp mesh (device 2) was placed into the abdominal wall and secured it with sutures." (b)(6)2011 - patient was diagnosed with recurrent umbilical hernia thereby underwent open repair with implant of biological mesh.(note: no operative note regarding this procedure is documented in the available medical records.) (b)(6)2016 - patient was diagnosed with recurrent ventral hernia without obstruction, pain, thereby underwent open repair with primary hernia repair, vac placement.(note: no operative note regarding this procedure is documented in the available medical records.).
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.Note, the manufacturing date (15-jul-2010) is considered to be a best estimate.This emdr represents the composix lp mesh (device 2).An additional supplemental emdr was submitted to represent the ventralex 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.

• 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 ; +1(800)556-6756
• MDR Report Key: 50382861
• Report Number: 1213643-2026-01085
• Device Sequence Number: 21273243
• Product Code: FTL
• UDI-Device Identifier: 00801741031267
• UDI-Public: (01)00801741031267(17)150828(10)HUUG1143
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K061754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2026

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 Expiration Date: 08/28/2015
• Device Catalogue Number: 0134450
• Device Lot Number: HUUG1143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2010
• 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 Sex: Female
• Patient Weight: 220 LB