MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALEX; SURGICAL MESH

Catalog Number	0010301
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Obstruction/Occlusion (2422)
Date of Event	12/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2006 - patient was diagnosed with epigastric and umbilical hernia thereby underwent open repair with implant of ventralex mesh (device 1 and 2).Per op notes, ¿a vertical incision was made over the palpable mass in the epigastrium superior to the umbilicus region.The underlying protuberant cystic structure was identified and reduced.A ventralex mesh (device 1) was placed and secured on either side with sutures.Umbilicus defect was identified and a curvilinear incision was made.The hernia was identified.A ventralex mesh (device 2) was placed and secured with sutures.¿ on (b)(6) 2022, patient was diagnosed with small bowel obstruction thereby underwent robotic assisted laparoscopic repair.Per op notes, ¿small bowel was noted be distended with multiple loops of small bowel noted to be hyperemic and adherent to a previous mesh (device 1 and 2) in the anterior abdominal wall.Collapsed small bowel was noted distal to one of these adhesion points.The small bowel was released from the mesh and anterior abdominal wall.Two point serosal injuries were noted and primarily repaired with sutures.¿.
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 mdr represents the ventralex 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: VENTRALEX
• 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 ; 8005566756
• MDR Report Key: 24710043
• Report Number: 1213643-2026-00380
• Device Sequence Number: 5652378
• Product Code: FTL
• UDI-Device Identifier: 00801741000355
• UDI-Public: (01)00801741000355(10)UNKAA077
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K132441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2026

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 Catalogue Number: 0010301
• Device Lot Number: UNKAA077
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 87 KG