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

Catalog Number	5959360
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Hernia (2240)
Date of Event	03/23/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2010 - patient was diagnosed with ventral incisional hernia thereby underwent laparoscopic repair with implant of sepramesh ip (device 1).Per op notes, ¿all the adhesions were taken down.The hernia defect was entered and reduced.A sepramesh ip (device 1) was placed and tacked using sorbafix tacker.¿ on (b)(6) 2013 - patient was diagnosed with adhesions thereby underwent open repair.Per op notes, ¿the prior mesh (device 1) was encountered and opened.Large amount of old scar was noted behind the prior mesh and excised the scar.Adhesions of omentum, colon and small bowel were lysed.All the adhesions were lysed.Resection of gastrointestinal anastomosis from previous vagotomy and partial gastrotomy was performed.¿ on (b)(6) 2014 - patient was diagnosed with adhesions and abdominal pain thereby underwent laparoscopic repair.Per op notes, ¿adhesions anterior abdominal wall was lysed.A large prior mesh (device 1) noted in upper abdomen was intact.Dense adhesions lysed.Internal hernia defect was noted and repaired with sutures.¿ on (b)(6) 2014 - patient was diagnosed with two ventral incisional hernia thereby underwent laparoscopic repair with implant of ventralight st (device 2 and 3).Per op notes, ¿adhesions of abdominal wall were taken down.The prior mesh (device 1) in the midline was noted.The one hernia defect was identified above the umbilicus, and another one identified below the umbilicus.A ventralight st (device 2) was placed in the upper midline and another ventralight st (device 3) was placed in the lower midline.Both meshes were placed over the defect by overlapping the old mesh (device 1) and secured with tacks.¿ on (b)(6) 2016 - patient was diagnosed with possible epigastric ventral hernia, adhesions and pain thereby underwent repair with partial excision of sepramesh ip (device 1) and ventralight st (device 2 and 3).Were op notes, ¿in midline there was some pieces of ballooning of meshes.The prior meshes (device 1,2 and 3) were protruding through the fascia.Adhesions of abdominal cavity were lysed.There was an eventration of prior mesh (device 1,2 and 3) not a true hernia through mesh.Decreased the size of the prior meshes (device 1,2 and 3) by trimming some of both sides to prevent eventration again.The jejunum was twisted and obstructed, and ischemic part was resected.The mesenteric defect was closed with sutures.¿.
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 bd sepramesh ip (device 1).Additional supplemental emdrs were submitted to represent the bd ventralight st mesh.(device 2 and 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: 23848265
• Report Number: 1213643-2025-01244
• Device Sequence Number: 21218287
• Product Code: FTL
• UDI-Device Identifier: 00801741031809
• UDI-Public: (01)00801741031809(17)110128(10)WBTGS099
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/17/2025

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: 01/28/2011
• Device Catalogue Number: 5959360
• Device Lot Number: WBTGS099
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 12/19/2025
• 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