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

Catalog Number	5954600
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Erosion (1750); Unspecified Infection (1930); Pain (1994); Strangulation (2084); Hernia (2240); Injury (2348); Disability (2371)
Date of Event	09/04/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.No lot number has been provided; therefore a review of the manufacturing records is not possible at this time.No medical records have been provided.Information is limited at this time.Should additional information be provided a supplemental emdr will be submitted.Note: the information provided by bard 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 bard.Not returned.
Event or Problem Description
The following was alleged by the patient's attorney: on (b)(6) 2015: the patient underwent surgery for implant of an unspecified bard/davol ventralight st.The patient is making a claim for an adverse patient outcome against the bard/davol ventralight st.The attorney alleges general allegations for ¿past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient.¿.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2015: the patient underwent surgery for implant of an unspecified bard/davol ventralight st.The patient is making a claim for an adverse patient outcome against the bard/davol ventralight st.The attorney alleges general allegations for ¿past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient.¿ addendum per additional information provided: (b)(6) 2015 ¿ patient was diagnosed with parastomal hernia thereby underwent laparoscopic repair with implant of ventralight st mesh.Per operative notes, ¿the adhesions about the hernia taken down.The sac was removed.The defect was measured, and a ventralight st mesh was placed and tacked.¿ (b)(6) 2015 ¿ patient was diagnosed with strangulated incarcerated parastomal hernia thereby underwent open repair.Per operative notes, ¿adhesions were taken down.The parastomal hernia was identified and appeared to be a loop of bowel going up into the parastomal hernia.The bowel that was incarcerated in the parastomal hernia was reduced back into the peritoneal cavity.A section of small bowel was resected.The defect was closed using sutures.¿ (b)(6) 2015 ¿ patient was diagnosed with peristomal infection secondary to bowel eroding into the mesh thereby underwent open repair with removal of ventralight st mesh.Per operative notes, ¿adhesions were taken down.The ventralight st mesh was removed.The peritoneal cavity was closed using sutures.¿.
Additional Manufacturer Narrative
At this time no conclusions can be made.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.No medical records have been provided.Information is limited at this time.Addendum: this supplemental emdr is submitted to document additional information provided.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-oct-2014) is considered to be a best estimate.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 ; 4018258495
• MDR Report Key: 7891092
• Report Number: 1213643-2018-03172
• Device Sequence Number: 2488413
• Product Code: FTL
• UDI-Device Identifier: 00801741031632
• UDI-Public: (01)00801741031632(17)161028(10)HUYJ1557
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2025

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: 10/28/2016
• Device Catalogue Number: 5954600
• Device Lot Number: HUYJ1557
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2018
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 12/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2014
• 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: Disability; Required Intervention; Life Threatening
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 85 KG