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

Catalog Number	5950007
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Erosion (1750); Scar Tissue (2060); Insufficient Information (4580)
Date of Event	03/17/2021
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 : 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 ventralex mesh.Case-specific details not provided.
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 ventralex mesh.Case-specific details not provided.Addendum per information provided by patient's attorney: (b)(6) 2017 - patient was diagnosed with umbilical hernia thereby underwent repair with implant of ventralex st mesh.Per operative notes, ¿a supraumbilical curvilinear incision was made above the true umbilical hernia, the hernia sac was reduced.A ventralex st mesh was inserted to a 2 cm defect and sutured.¿ (b)(6) 2021 - patient visited hospital for mesh protruding on one side of his abdomen to the extent that has to cut off the edges.There are no bowel symptoms, lumps or swelling.(b)(6) 2021 - patient visited hospital with mesh protrusion.There is no evidence of recurrence but can feel bits of the mesh coming out of his scar and remains symptomatic.
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 a post-op complication.Per medical records review, about few years post implant of ventralex st, patient was diagnosed with erosion, scarring thereby underwent partial mesh removal.The instructions-for-use supplied with the device list erosion as a possible complication.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in apr 2017.Updated fields: a2, a4, b3, b4, b5, b7, d4, d6.A, d6.B, g3, g6, h2, h4, h6, h10, h11 corrected field: b2 (event attributed to) and d3 (date of event).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: VENTRALEX ST
• 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: 19211385
• Report Number: 1213643-2024-00190
• Device Sequence Number: 20882557
• Product Code: FTL
• UDI-Device Identifier: 00801741031472
• UDI-Public: (01)00801741031472(17)190228(10)HUBN1715
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K101928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2024

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: 02/28/2019
• Device Catalogue Number: 5950007
• Device Lot Number: HUBN1715
• 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
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2017
• 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: Required Intervention; Other
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 96 KG