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

Catalog Number	0010302
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Fistula (1862); Hernia (2240); Bowel Perforation (2668); Insufficient Information (4580)
Date of Event	01/07/2011
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-jun-2025 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.
Event or Problem Description
Attorney alleges patient he represents has experience unspecified injury.Attorney alleges this patient was treated with a ventralex mesh.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 review of information provided by the patient¿s attorney, root cause is inconclusive.Information showed the patient had been implanted with multiple mesh devices.No conclusion can be made as to the extent to which the bd/bard implant may have caused or contributed to the patient's postoperative course.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 patient he represents has experience unspecified injury.Attorney alleges this patient was treated with a ventralex mesh.Case-specific details not provided.Addendum per additional information provided: (b)(6) 2007 - patient was diagnosed with para umbilical hernia thereby underwent laparoscopic repair with implant of synthetic mesh.Per op notes, "a synthetic mesh was placed and tacked." (b)(6) 2007 - patient was diagnosed with reducible port site hernia thereby underwent open repair with implant of ventralex mesh.(note: no implant op notes were provided for this procedure.) (b)(6) 2008 - patient was diagnosed with recurrent para umbilical hernia thereby underwent open repair.Per op notes, "the previously placed synthetic mesh was retracted medially.There was a lit bit of filmy adhesions.The mesh was reattached and sutured." (b)(6) 2011 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with implant of unknown mesh.(note: no implant op notes were provided for this procedure.) (b)(6) 2023 - patient was diagnosed with small bowel perforation, fistula, recurrent incisional hernia thereby underwent open repair with removal of ventralex mesh.Per op notes, ¿adhesions were lysed.Two meshes, one synthetic and ventralex mesh were identified.The ventralex mesh was excised.¿.

• Brand Name: MESH ¿ VENTRALEX
• 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: 22306674
• Report Number: 1213643-2025-00513
• Device Sequence Number: 15599923
• Product Code: FTL
• UDI-Device Identifier: 00801741016479
• UDI-Public: (01)00801741016479(17)120728(10)HURF1430
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K132441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

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: 07/28/2012
• Device Catalogue Number: 0010302
• Device Lot Number: HURF1430
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 47 YR
• Patient Sex: Female
• Patient Weight: 114 KG