MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST W/ ECHO; SURGICAL MESH

Catalog Number	5955680
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	12/13/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Per medical records and plaintiff profile form: (b)(6) 2005: patient was diagnosed with incarcerated incisional hernia thereby underwent open repair with implant of kugel patch (device 1).Per op notes, ¿previous upper midline incision was excised.The hernia sac was identified and bowel contents were reduced.A kugel patch (device 1) was placed into the peritoneal cavity with ptfe portion to the abdominal organs and the polypropylene portion adjacent to the anterior abdominal wall, then secured in place around the fascial defect with suture.¿ (b)(6) 2007: patient was diagnosed with recurrent incisional hernia thereby underwent open repair with implant of synthetic mesh and excision of kugel patch (device 1).Per op notes, ¿the midline incision was made through the previous scar and carried down to the hernia sac.Previous mesh (device 1) was noted to be folded back on itself.The mesh was completely removed.The right lateral aspect appeared to have heterotrophic calcification and this was removed.Adhesions were lysed.The intraabdominal placement of synthetic mesh was performed and secured with suture.¿ (b)(6) 2009: patient was diagnosed with incarcerated small bowel with recurrent hernia with infected mesh thereby underwent open repair with excision of synthetic mesh and implant of synthetic mesh.Per op notes, ¿a midline incision was made.The mesh was identified and a fluid filled sac was noted.Incarcerated small bowel was also noted.The synthetic mesh was removed.The small bowel was eviscerated and adhesions were lysed.The portion that was incarcerated in the knuckle was identified and serosal area was oversewn with suture.A synthetic mesh was placed and secured with sutures.¿ (b)(6) 2010: patient was diagnosed with incarcerated ventral incisional hernia with small bowel obstruction thereby underwent laparoscopic repair.Per op notes, ¿the area of incarceration with the knuckle of bowel was reduced.The small bowel was inspected after complete reduction of the hernia and was found to be viable.The defect was a wide mouth opening and no attempt at hernia repair was made.¿ (b)(6) 2010: patient was diagnosed with recurrent incarcerated incisional hernia thereby underwent laparoscopic repair with implant of synthetic mesh.Per op notes, ¿the complex ventral incisional hernia was noted with multiple smaller hernias within the hernia.The lateral dimension of the fascial defect and caudad/cephalad dimension, with the upper portion being more attenuated.A synthetic mesh was placed and secured with tacks.¿ (b)(6) 2015: patient was diagnosed with recurrent incarcerated ventral hernia thereby underwent laparoscopic assisted repair with implant of ventralight st with echo ps (device 2 and 3).Per op notes, ¿a midline incision was made from the upper portion of abdomen and down to the lower portion.Adhesions of the small bowel to the mesh was noted and the small bowel was divided away from the mesh.The hernia had incarcerated small bowel and over to the right side it was fairly large.Small bowel was dissected out and lysed from hernia.The midline defect was primarily repaired with suture.A ventralight st with echo ps (device 2) was placed in a longitudinal fashion in the lower portion of abdomen in order to cover the large symptomatic defect and tacked with sorbafix suture.A second piece of ventralight st with echo ps (device 3) was placed in a longitudinal fashion to cover the midline incision and tacked into place with sorbafix suture.¿ (b)(6) 2016: patient was diagnosed with recurrent ventral hernia with incarcerated small bowel thereby underwent laparoscopic repair with implant of ventrio st mesh (device 4).Per op notes, ¿a mass was noted underneath the mesh.Hernia felt like a little further distally and to the right.The mesh (device 2 and 3) went out towards the edge of the rectus muscle.Extensive small bowel adhesions to mesh in the midline was noted.Hernia defect was located in the right lower abdomen.Weaker area in the midline was noted.Adhesions were taken down.A ventrio st mesh (device 4) was placed through the small midline incision and secured with suture.¿.
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-nov-2014) is considered to be a best estimate.This emdr represents the ventralight st with echo ps (device 3).Additional supplemental emdrs were submitted to represent bard kugel patch (device 1) and bard ventralight st with echo ps (device 2).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: VENTRALIGHT ST W/ ECHO
• 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: 24766470
• Report Number: 1213643-2026-00427
• Device Sequence Number: 9298447
• Product Code: FTL
• UDI-Device Identifier: 00801741031755
• UDI-Public: (01)00801741031755(17)161128(10)HUYK0131
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K122436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2026

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: 11/28/2016
• Device Catalogue Number: 5955680
• Device Lot Number: HUYK0131
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2014
• 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: 45 YR
• Patient Sex: Female
• Patient Weight: 127 KG