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

Catalog Number	5959360
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240); Insufficient Information (4580)
Date of Event	06/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient.The patient's attorney alleges that the patient had subsequent surgical intervention; 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 sepramesh ip (device #1).Additional emdrs were submitted to represent the two bard/davol mesh ¿ ventralex (device #2 & device #3).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 sepramesh ip on (b)(6) 2013 and two ventralex hernia patches on (b)(6) 2020.As reported, the patient is making a claim for an adverse patient outcome against all devices.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.It is also alleged that the patient experienced emotional distress and the device was defective.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol sepramesh ip on (b)(6) 2013 and two ventralex hernia patches on (b)(6) 2020.As reported, the patient is making a claim for an adverse patient outcome against all devices.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.It is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2013 - patient was diagnosed with ventral hernia and umbilical hernia thereby underwent open repair with implant of sepramesh ip (device 1).Per op notes, ¿the ventral hernia sac was identified and reduced.The umbilical hernia sac was identified and reduced.Both hernias were combined.Adhesions were taken down.A sepramesh ip (device 1) was placed using sutures.¿ (b)(6) 2020 - patient was diagnosed with recurrent ventral hernia and left lower quadrant incisional hernia thereby underwent open repair with implant of ventralex st (device 2 and 3).Per op notes, ¿the ventral hernia sac was identified, dissected and reduced.A ventralex st (device 2) was placed and sutured.An incisional hernia sac was identified on the left lower quadrant from prior robotic surgery was identified and reduced.A ventralex st (device 3) was placed and sutured.¿ (b)(6) 2020 - patient was diagnosed with recurrent incisional hernia thereby underwent robotic assisted repair with excision of ventralex st (device 2) and implant of ventralight st using echo ps (device 4).Per op notes, ¿several adhesions from the omentum to abdominal wall were lysed.The ventralex st (device 2) with seroma was noted and evacuated.The prior mesh (device 2) deteriorated.A ventralight st using echo ps (device 4) was placed and sutured.¿.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient.The patient's attorney alleges that the patient had subsequent surgical intervention; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.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-may-2012) is considered to be a best estimate.Updated fields: a2, b3, b4, b5, b7, d3, d4, g3, g6, h2, h4, h6, h10.This supplemental emdr represents the sepramesh ip (device 1).An additional supplemental emdr was submitted to represent the bard/davol ventralex st mesh (device 2, device 3).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.

• Brand Name: SEPRAMESH IP
• 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: 11647845
• Report Number: 1213643-2021-02648
• Device Sequence Number: 3496974
• Product Code: FTL
• UDI-Device Identifier: 00801741031809
• UDI-Public: (01)00801741031809(17)140528(10)HUWE2172
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K063739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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: 05/28/2014
• Device Catalogue Number: 5959360
• Device Lot Number: HUWE2172
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2012
• 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
• Patient Age: 61 YR
• Patient Sex: Female