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

Catalog Number	5955790
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Necrosis (1971); Pain (1994); Injury (2348); Disability (2371)
Date of Event	08/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges that the patient had subsequent surgical intervention and "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"; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents the bard/davol ventralight st mesh (device #2).An additional emdr was submitted to represent the bard/davol mesh - ventralex (device #1).Should additional information be provided, a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol ventralex on (b)(6) 2017 and ventralight st on (b)(6) 2017.As reported, the patient is making a claim for an adverse patient outcome against both devices.It is alleged that the patient underwent surgery for the removal of hernia mesh on (b)(6) 2017.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." it is also alleged that the patient experienced emotional distress and the device was defective.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges that the patient had subsequent surgical intervention and "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"; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct the date of explant, brand name.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-2016) is considered to be a best estimate.Updated fields: a2, b4, b5, b6, b7, d3, d4 (product catalog no., udi no., corporate lot no., expiry date), g1, g3, g6, h2, h6, h10, h11.Corrected field: d1 (brand name), d.6b (date of explant).This supplemental emdr represents the bard/davol ventralight st w/ echo mesh (device 2).An additional emdr was submitted to represent the bard/davol mesh - ventralex (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.H3 other text: not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol ventralex on (b)(6) 2017 and ventralight st on (b)(6) 2017.As reported, the patient is making a claim for an adverse patient outcome against both devices.It is alleged that the patient underwent surgery for the removal of hernia mesh on (b)(6) 2017.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." it is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2017 - patient was diagnosed with umbilical hernia thereby underwent open repair with implant of ventralex mesh (device 1).Per op notes, ¿the hernia sac was identified and dissected.The sac was reduced.A 8 cm ventralex mesh (device 1) was placed and sutured.¿ (b)(6) 2017 - patient was diagnosed with recurrent ventral hernia with pain thereby underwent laparoscopic repair with partial excision of ventralex mesh (device 1) and implant of ventralight st using echo ps (device 2).Per op notes, ¿the hernia sac was identified and dissected.The adhesions of transverse colon were taken down.The sac was reduced.The old mesh (device 1) was identified and cut off; the remaining mesh was left in place.Omental adhesions were lysed.A ventralight st using echo ps (device 2) was placed and tacked using sutures.¿ (b)(6) 2017 - patient was diagnosed with fat necrosis, abdominal wall mass and abscess thereby underwent open repair with excision of ventralex mesh (device 1).Per op notes, ¿abscess was drained.Adhesions were lysed.The abdominal mass was transected.The fat necrosis was excised.The remanent old mesh (device 1) was noted and excised entirely.The mesh (device 2) from prior surgery was intact and sutured.¿.

• 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 ; 4018258495
• MDR Report Key: 10743913
• Report Number: 1213643-2020-09778
• Device Sequence Number: 17014923
• Product Code: FTL
• UDI-Device Identifier: 00801741031762
• UDI-Public: (01)00801741031762(17)181228(10)HUAY2042
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K122436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

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: 12/28/2018
• Device Catalogue Number: 5955790
• Device Lot Number: HUAY2042
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2016
• 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: Disability; Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female