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

Catalog Number	5959680
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Abdominal Pain (1685)
Date of Event	09/21/2010
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2006 ¿ patient with a complex history for colostomy, perineal problems was diagnosed with paracolostomy hernia thereby underwent open repair with implant of collamend mesh (device #1).Per operative notes, ¿the hernia sac was identified and repaired with collamend mesh (device #1) and sutured.¿ (b)(6) 2007 - patient was diagnosed with incarcerated recurrent paracolostomy hernia, thereby underwent open repair.Per operative notes, ¿the hernia sac with fluid was reduced and sutured.¿ (b)(6) 2007 - patient was diagnosed with symptomatic paracolostomy hernia thereby underwent open repair with implant of composix kugel mesh (device #2).Per operative notes, ¿a large symptomatic paracolostomy hernia was identified and dissected.A composix kugel mesh (device #2) was placed around the defect and sutured.¿ (b)(6) 2008 - patient was diagnosed with recurrent paracolostomy hernia with colonic obstruction thereby underwent open repair with segmental colon resection.Per operative notes, ¿the paracolostomy hernia was identified above the previously placed mesh.The hernia defect was closed with sutures.¿ (b)(6) 2008 - patient was diagnosed with infected mesh in the right lower quadrant abdominal wall and recurrent ventral hernia in the left lower quadrant abdominal wall thereby underwent open repair with removal of collamend mesh (device #1) and implant of ventralex mesh (device #3).Per operative notes, ¿in the left lower quadrant, the hernia sac was identified, excised and placed with ventralex mesh (device #3) and sutured.In right lower quadrant, collamend mesh (device #1) was seen infected and completely excised.¿ (b)(6) 2009 - patient underwent debridement of abdominal wound, suture removal.There was no evidence of abscess or residual mesh in the base of the wound.(b)(6) 2009 - patient was diagnosed with paracolostomy hernia thereby underwent open repair.The hernia was identified and excised.A prolapsed portion of colon was removed and repaired with sutures.(b)(6) 2009 - patient was diagnosed with chronic pericolostomy abscess and underwent translocation of colostomy from right to left upper quadrant abdominal wall & repair of old colostomy site with implant of allomax (device #4).Per operative notes, ¿hernia sac was identified.Sutures placed for hernia repair noted to cause abscess.The hernia defect was repaired with allomax and sutured.¿ (b)(6) 2010 - patient was diagnosed with recurrent multiple ventral hernias thereby underwent laparoscopic repair with the implant of sepramesh ip (device #5).Per operative notes, ¿the adhesions were lysed.There were multiple small hernias identified.The sepramesh ip was trimmed and placed superiorly coming around just the lower edge of the stoma and then inferiorly also and tacked." (b)(6) 2010 - patient was diagnosed with chronic left lower abdominal pain thereby underwent open repair with removal of mesh (device #4 and #5).Per operative notes, ¿went directly down to mesh where there was a lot of prolene and mesh prosthesis from a previous onlay patch.By dissecting directly under the patch, we were able to enter a plane where there was an old hernia cavity and no direct involvement or no exposure of bowel was seen as the mesh prosthesis was removed including suture from the abdominal wall.¿.
Additional Manufacturer Narrative
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.This emdr represents the sepramesh ip (device #5).An additional emdr was submitted to represent the collamend mesh (device #1).Additional supplemental emdrs were submitted to represent and composix kugel mesh (device #2) and ventralex mesh (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.

• 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 ; 8005566756
• MDR Report Key: 22164019
• Report Number: 1213643-2025-00442
• Device Sequence Number: 12617890
• Product Code: FTL
• UDI-Device Identifier: 00801741031823
• UDI-Public: (01)00801741031823(17)100728(10)WBTE5058
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K063739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• 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: 07/28/2010
• Device Catalogue Number: 5959680
• Device Lot Number: WBTE5058
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 06/07/2025
• 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: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female