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

Catalog Number	5954113
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abscess (1690); Fistula (1862)
Date of Event	03/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information received, on (b)(6) 2017, patient was diagnosed with incarcerated incisional hernia, thereby underwent open repair with implant of ventrio mesh (device 1).Per op notes, ¿a longitudinal incision was made from the previous scar.The hernia sac was identified.Multiple adhesions between the hernia sac in the small intestine was noted and adhesiolysis was performed.A ventrio mesh (device 1) was placed into the abdomen and secured in two places with sutures.A small defect in the upper central portion of the mesh was noted and drains were placed.¿ on (b)(6) 2017 patient was diagnosed with abdominal wall abscess, thereby underwent open repair of incision and drainage.Per op notes, ¿the wound was opened and purulent fluid was noted.Granulation tissue was noted at the periphery of the wound and there was no exposed mesh present.Wound vac dressing applied.¿ on (b)(6) 2017, patient was diagnosed with abdominal wall abscess x 2, thereby underwent open repair of incision and drainage.Per op notes, ¿abscess cavity was noted in the subcutaneous tissues.Purulent fluid was noted to be emanating from the inferior aspect of the wound where the previous wound vac in place.The wound was opened up connecting both areas of purulent drainage.A small amount of exposed mesh in the inferior aspect of the wound.A wound vac dressing was applied and secured with drape.¿ on (b)(6) 2017, patient was diagnosed with abdominal wall abscess, infected mesh and intraabdominal abscess, thereby underwent open repair with excision of ventrio mesh (device 1).Per op notes, ¿two open wounds, one to the superior aspect and one to the lower aspect of the abdomen were noted.An incision was made connecting two openings.Due to the deep nature of infection, the wound was opened and wound vac placed.The ventrio mesh (device 1) was excised, small bowel enterotomy was created and repaired with sutures.¿ on (b)(6) 2018, patient had open abdominal wound, thereby underwent skin graft split thickness lower extremity and skin graft bilateral thighs to abdominal wall.On (b)(6) 2018, patient had enterocutaneous fistula, thereby underwent laparotomy, extensive lysis of adhesions and small bowel resection.On (b)(6) 2020, patient underwent open repair with implant of ventralight st mesh (device 2).Per op notes, ¿the midline incision was made.Adhesions were noted and lysed.A ventralight st mesh (device 2) was placed and secured with sutures.¿ on (b)(6) 2021, patient was diagnosed with enterocutaneous fistula, thereby underwent open repair with debridement of abdominal wall, unroofing of fistula tract and wound vac placement.Per op notes, ¿two abscess cavities appeared to lead to small ecf.Granulation tissue was cauterized and skin was excised.Wound vac was placed and secured.¿.
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-apr-2019) is considered to be a best estimate.This mdr represents the ventralight st mesh (device 2).An additional emdr was submitted to represent the ventrio 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: VENTRALIGHT ST MESH
• 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: 24686452
• Report Number: 1213643-2026-00362
• Device Sequence Number: 9903223
• Product Code: FTL
• UDI-Device Identifier: 00801741031595
• UDI-Public: (01)00801741031595(17)210428(10)HUDR1274
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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 Expiration Date: 04/28/2021
• Device Catalogue Number: 5954113
• Device Lot Number: HUDR1274
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2019
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 118 KG