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

Catalog Number	5954810
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Abscess (1690); Erosion (1750); Purulent Discharge (1812); Sepsis (2067); Insufficient Information (4580)
Date of Event	07/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges unspecified adverse patient outcome associated with the use of hernia mesh.The degree to which the device used to treat the patient may have caused or contributed to a post-op complication is unknown.No lot number has been provided, a review of the manufacturing records is not possible.Note, the date of event is considered to be a best estimate as 10-apr-2024 based on the date of awareness.Should additional information be provided, a supplemental emdr will be submitted.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: device not returned.
Event or Problem Description
Attorney alleges multiple patients he represents have experience unspecified injury and allege they may have required additional medical/surgical treatment.Attorney alleges this patient was treated with a ventralight st.Case-specific details not provided.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges unspecified adverse patient outcome associated with the use of hernia mesh.The degree to which the device used to treat the patient may have caused or contributed to a post-op complication is unknown.No lot number has been provided, 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 event date.Based on the information received, no conclusions can be made as the degree to which the device used to treat the patient may have caused or contributed to the post-op complications.Per medical records review, post implant of the ventralight st mesh, the patient was diagnosed with wound dehiscence, purulent discharge, erosion and sepsis.Note the medical records note that "features of sepsis due to previous stercoral perforation." the relationship between the sepsis and the implant are unclear; however it appears the sepsis diagnosis is not related to the mesh implant.The adverse reactions section of the instructions-for-use supplied with the device identifies erosion as a possible complication.The warning section states, "the use of any permanent mesh or patch in a contaminated or infected wound could lead to fistula formation and/or extrusion of the mesh." review of manufacturing records confirms product was made to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in (b)(6) 2017.This supplemental mdr represents the ventralight st (device #2).An additional mdr was submitted to represent the collamend fm (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.
Event or Problem Description
Attorney alleges multiple patients he represents have experience unspecified injury and allege they may have required additional medical/surgical treatment.Attorney alleges this patient was treated with a ventralight st.Case-specific details not provided.Addendum per information provided by patient's attorney: (b)(6) 2014 - patient was diagnosed with incisional hernia and parastomal hernia thereby underwent open repair with the implant of collamend fm mesh (device #1).Per operative notes, ¿adhesions were taken down.Collamend fm mesh is inserted directly and sutured.¿ (b)(6) 2014 to (b)(6) 2018 - during multiple visits patient had abdominal pain, hematoma, abscess, recurrent incisional hernia and became unwell with features of sepsis due to previous stercoral perforation with presence of erythema.(b)(6) 2018 - patient was diagnosed with recurrent incisional hernia thereby underwent open abdominal wall reconstruction with the implant of ventralight st (device #2) and partial explant of collamend fm (device #1).Per operative notes, ¿hernia sac was identified.The old mesh (device #1) was released whereas not able to remove all the mesh.A ventralight st mesh (device #2) was placed and sutured in a sublay position.¿ (b)(6) 2018 to (b)(6) 2022 - during multiple visits patient had abdominal pain, wound dehiscence, skin lesion just lateral to previous abdominal scar, purulent discharge from wound sinus, sepsis and had eroding mesh.This file represents ventralight st (device #2).
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges unspecified adverse patient outcome associated with the use of hernia mesh.The degree to which the device used to treat the patient may have caused or contributed to a post-op complication is unknown.No lot number has been provided, a review of the manufacturing records is not possible.Addendum #1: h11: this supplemental emdr is submitted to document additional information provided and to correct the event date.Based on the information received, no conclusions can be made as the degree to which the device used to treat the patient may have caused or contributed to the post-op complications.Per medical records review, post implant of the ventralight st mesh, the patient was diagnosed with wound dehiscence, purulent discharge, erosion and sepsis.Note the medical records note that "features of sepsis due to previous stercoral perforation." the relationship between the sepsis and the implant are unclear; however, it appears the sepsis diagnosis is not related to the mesh implant.The adverse reactions section of the instructions-for-use supplied with the device identifies erosion as a possible complication.The warning section states, "the use of any permanent mesh or patch in a contaminated or infected wound could lead to fistula formation and/or extrusion of the mesh." review of manufacturing records confirms product was made to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in june 2017.Updated fields: a2, a4, b4, b5, b7, d4, d6.A, g3, g6, h2, h4, h6, h10, h11.Corrected fields: b2 (event attributed to), b3 (date of event).Addendum #2: this supplemental emdr is submitted to document additional information provided.Based on the information received, no conclusions can be made as the degree to which the device used to treat the patient may have caused or contributed to the post-op complication.Updated fields: b4, b5, b6, g3, g6, h2, h6, h10.This supplemental mdr represents the ventralight st (device #2).An additional supplemental mdr was submitted to represent the collamend fm (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.
Event or Problem Description
Attorney alleges multiple patients he represents have experience unspecified injury and allege they may have required additional medical/surgical treatment.Attorney alleges this patient was treated with a ventralight st.Case-specific details not provided.Addendum (1) per information provided by patient's attorney: (b)(6) 2014 - patient was diagnosed with incisional hernia and parastomal hernia thereby underwent open repair with the implant of collamend fm mesh (device #1).Per operative notes, ¿adhesions were taken down.Collamend fm mesh is inserted directly and sutured.¿ (b)(6) 2014 to (b)(6) 2018 - during multiple visits patient had abdominal pain, hematoma, abscess, recurrent incisional hernia and became unwell with features of sepsis due to previous stercoral perforation with presence of erythema.(b)(6) 2018 - patient was diagnosed with recurrent incisional hernia thereby underwent open abdominal wall reconstruction with the implant of ventralight st (device #2) and partial explant of collamend fm (device #1).Per operative notes, ¿hernia sac was identified.The old mesh (device #1) was released whereas not able to remove all the mesh.A ventralight st mesh (device #2) was placed and sutured in a sublay position.¿ (b)(6) 2018 to (b)(6) 2022 - during multiple visits patient had abdominal pain, wound dehiscence, skin lesion just lateral to previous abdominal scar, purulent discharge from wound sinus, sepsis and had eroding mesh.Addendum (2) per information provided by patient's attorney: (b)(6) 2022 - patient underwent drainage of abdominal wall abscess.This file represents device#2 (ventralight st).

• 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: 19214764
• Report Number: 1213643-2024-00216
• Device Sequence Number: 8105383
• Product Code: FTL
• UDI-Device Identifier: 00801741031687
• UDI-Public: (01)00801741031687(17)190428(10)HUBS0278
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/06/2025

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: 04/28/2019
• Device Catalogue Number: 5954810
• Device Lot Number: HUBS0278
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2024
• Supplement Date Received by Manufacturer: 07/30/2024; 05/19/2025
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 08/27/2024; 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2017
• 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: Life Threatening; Other; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 90 KG