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

Catalog Number	5959480
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Seroma (2069); Obstruction/Occlusion (2422)
Date of Event	03/16/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per medical records review, about few days post implant of sepramesh ip, patient was diagnosed with obstruction, seroma thereby underwent repair with mesh removal.The instructions-for-use supplied with the device list seroma as a possible complication.Review of manufacturing records confirms product was manufactured to specification.Note the, manufacturing date (15-dec-2010) is considered to be a best estimate.This emdr represents the sepramesh ip (device #2).An additional supplemental emdr was submitted to represent the sepramesh ip (device #1).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
Per information provided: (b)(6) 2011 - patient was diagnosed with incisional hernia, seroma thereby underwent laparoscopic repair with the implant of sepramesh ip (device #1 & #2) on.Per operative notes, ¿at lower anterior abdominal wall, there was a piece of polypropylene mesh as an inlay to the medial border of the right rectus muscle down about halfway between the patient's umbilicus and pubis.A largest defect lateral to the strip of polypropylene mesh had inflammatory adhesions, thick hernia sac were taken down.A piece of sepramesh ip (device #1) was placed intra-abdominally and the inferior border of the mesh was fixed to cooper ligament and the pubic tubercle using tackers.The medial border of the mesh was fixed to the lateral border of the right rectus.Superiorly, the mesh was fixed with fascial fixation sutures just above the left anterior superior iliac spine.The umbilical hernia was repaired using a piece of sepramesh ip (device #2) and secured with tacks.The seroma was drained.¿ (note: the mesh previously placed was unknown.) (b)(6) 2011- patient was diagnosed with small bowel obstruction thereby underwent removal of sepramesh ip (device #2) and implant of sepramesh ip (device #3).Per operative notes, ¿in umbilicus, hernia sac was identified, and seroma was encountered in space above the sepramesh ip (device #2).The old umbilical mesh (device #2) and sutures were removed.On right side, hernia defect was incarcerated with knuckle of bowel.The mesh (device #1) had separated a bit from the rectus muscle.Because of this, a loop of bowel had snucked through the hernia and obstructed.Eviscerated the small bowel and adhesive band was lysed.A piece of sepramesh ip (device #3) was cut it into a roughly trapezoidal shape and placed underlay to the fascial defect and anchored with sutures.The inferior border of the new mesh (device #3) to the superior border of the old mesh.The seroma was drained." attorney alleges that the patient had adhesions, bowel obstruction, seroma, pain and suffering.

• 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: 21455889
• Report Number: 1213643-2025-090106
• Device Sequence Number: 7763976
• Product Code: FTL
• UDI-Device Identifier: 00801741031816
• UDI-Public: (01)00801741031816(17)121228(10)HUUL0125
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K063739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/25/2025

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: 12/28/2012
• Device Catalogue Number: 5959480
• Device Lot Number: HUUL0125
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2010
• 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: 58 YR
• Patient Sex: Female