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

Catalog Number	5959680
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Insufficient Information (4580)
Date of Event	02/12/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol sepramesh ip on (b)(6) 2013.As reported, the patient is making a claim for an adverse patient outcome against the sepramesh ip.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.Attorney alleges that the patient experienced emotional distress and the device was defective.
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.Should additional information be provided, a supplemental emdr will be submitted.
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-feb-2012) is considered to be a best estimate.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.H11: 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 that the patient underwent surgery for implant of an unspecified bard/davol sepramesh ip on (b)(6) 2013.As reported, the patient is making a claim for an adverse patient outcome against the sepramesh ip.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.Attorney alleges that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2013 - patient was diagnosed with recurrent umbilical hernia thereby underwent laparoscopic repair with implant of sepramesh ip.Per op notes, "a sepramesh ip was placed and sutured." (b)(6) 2014 - patient was diagnosed with pelvic pain thereby underwent laparoscopic lysis of adhesions.Per op notes, "lysis of adhesions was performed and the previous mesh was seen to be in good position." (b)(6) 2014 - patient was diagnosed with recurrent multiple hernias, hiatal hernia thereby underwent laparoscopic repair.Per op notes, "adhesions were lysed and all the defects were repaired using sutures.".

• 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: 12867090
• Report Number: 1213643-2021-08877
• Device Sequence Number: 11634227
• Product Code: FTL
• UDI-Device Identifier: 00801741031823
• UDI-Public: (01)00801741031823(17)140228(10)HUWB1824
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/27/2025

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: 02/28/2014
• Device Catalogue Number: 5959680
• Device Lot Number: HUWB1824
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2021
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2012
• 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: 34 YR
• Patient Sex: Female