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

Catalog Number	5959124
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Defective Device (2588); Insufficient Device Problem Information (3190); Migration (4003)
Health Effect - Clinical Codes	Abscess (1690); Unspecified Infection (1930); Injury (2348)
Date of Event	11/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges 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.Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol sepramesh ip on (b)(6) 2015.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device(s).As reported, the patient is making a claim for an adverse patient outcome against the bard/davol sepramesh ip.As reported, the attorney alleges patient experienced emotional distress and the device was defective.
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges 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-mar-2014) is considered to be a best estimate.Updated fields: a2, a4, b2, b3, b4, b5, b7,d3, d4 (catalog no, lot no, udi, expiry date), d.6b (date of explant), g1, g3, g4, g6, h2, h4, h6, h10.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 that the patient underwent surgery for implant of an unspecified bard/davol sepramesh ip on (b)(6) 2015.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device(s).As reported, the patient is making a claim for an adverse patient outcome against the bard/davol sepramesh ip.As reported, the attorney alleges patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2015 - patient was diagnosed with incisional ventral hernia thereby underwent open repair with implant of sepramesh ip.Per operative notes, ¿a large hernia sac was identified and dissected free.The adhesions were lysed.A sepramesh ip was placed using prolene sutures.¿ (b)(6) 2017 - patient was diagnosed with abdominal wall abscess thereby underwent open repair with drainage of abdominal wall abscess.Per operative notes, ¿the abscess cavity was identified and opened.Significant amount of pus was removed.The prior mesh was noted.Abscess cavity was drained.¿ (b)(6) 2018 - patient was diagnosed with abdominal wall abscess thereby underwent open repair with drainage of abdominal wall abscess.Per operative notes, ¿the abscess pocket was noted near the mesh.The abscess cavity was drained.¿ (b)(6) 2018 - patient was diagnosed with infected mesh thereby underwent open repair with partial excision of sepramesh ip.Per operative notes, ¿the unincorporated edges of mesh were identified and removed.¿ (b)(6) 2018 - patient was diagnosed with infected wound and mesh protrusion thereby underwent repair with excision of mesh.Per operative notes, ¿large amount of yellowish green fluid was drained.The protruded mesh was removed.The sepramesh ip was excised.Wound vac was placed.¿.

• 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: 9348588
• Report Number: 1213643-2019-11333
• Device Sequence Number: 2106576
• Product Code: FTL
• UDI-Device Identifier: 00801741031793
• UDI-Public: (01)00801741031793(17)160328(10)HUYC1272
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K063739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2025

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: 03/28/2016
• Device Catalogue Number: 5959124
• Device Lot Number: HUYC1272
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2019
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 11/20/2019
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2014
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 145 KG