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

Catalog Number	5950007
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	11/09/2018
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.Note, the manufacturing date (15-feb-2016) is considered to be a best estimate.This emdr represents the ventralex st mesh (device 4).Additional supplemental emdrs and an emdr were submitted to represent the perfix plug (device 1), composix kugel mesh (device 2) and ventralex st mesh (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.
Event or Problem Description
Per information provided: (b)(6) 2010 - patient was diagnosed with umbilical hernia thereby underwent open repair with the implant of perfix plug (device 1).Per op notes, "incision to the umbilicus, a large perfix plug (device 1) was placed into the defect using prolene sutures." (b)(6) 2010 - patient was diagnosed with recurrent umbilical hernia thereby underwent open repair with the removal of mesh (device 1) and implant of composix kugel mesh (device 2).Per op notes, "the previously placed mesh (device 1) was palpable.It was dissected free, extracted and discarded.A small composix kugel mesh (device 2) was placed into the subfascial position with prolene sutures." (b)(6) 2013 - patient as diagnosed with recurrent umbilical hernia thereby underwent laparoscopic repair with the removal of mesh (device 2).Per op notes, "the previously placed mesh (device 2) was removed.Then a synthetic mesh was placed to the abdomen." (b)(6) 2016 - patient was diagnosed with recurrent ventral incisional hernia thereby underwent open repair with the implant of two ventralex st meshes (device 3 and device 4).Per op notes, "attention to the right mid abdomen, a mediumventralex st mesh (device 3) was placed into the defect using prolene sutures.Then attention to the left lower quadrant , a small ventralex st mesh (device 4) was placed using prolene sutures." (b)(6) 2018 - patient was diagnosed with recurrent ventral incisional hernia thereby underwent repair with the implant of ventrio st mesh (device 5).(notes: no op notes were provided).

• Brand Name: VENTRALEX ST
• 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: 25364462
• Report Number: 1213643-2026-00704
• Device Sequence Number: 10654590
• Product Code: FTL
• UDI-Device Identifier: 00801741031472
• UDI-Public: (01)00801741031472(17)180328(10)HUAP2129
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K101928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/29/2026

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: 03/28/2018
• Device Catalogue Number: 5950007
• Device Lot Number: HUAP2129
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2016
• 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: 62 YR
• Patient Sex: Female
• Patient Weight: 90 KG