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

Catalog Number	5959812
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Scar Tissue (2060); Hernia (2240); Obstruction/Occlusion (2422)
Date of Event	09/23/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2006 - patient was diagnosed with bilateral inguinal hernias and abscess, abdominal wound thereby underwent open repair with the implant of two bard flat mesh (device #3, device #4) on (b)(6) 2006.Per operative notes, ¿the right inguinal hernia was found.The floor of the direct inguinal hernia was repaired using a piece of bard flat mesh (device #3), which was placed with sutures.On left side, there was a large cord lipoma and attenuated floor consistent with direct inguinal hernia.The floor was repaired with bard flat mesh (device #4), which was placed in a similar fashion as on the right with sutures.The large, contracted wound was noted, and scar was excised.The purulent fluids were drained.¿ (b)(6) 2006 - patient had wound dehiscence, neuralgia thereby underwent open repair.Per operative notes, ¿on left groin, cloudy serosanguineous fluid was identified in the wound were rinsed.The bard flat mesh (device #4) was freed from the surrounding tissue.Due to extensive scarring, the spermatic cord was difficult to identify and lysis of the genital femoral nerve was performed.¿ (b)(6) 2006 - patient had left hydrocele thereby underwent hydrocelectomy.(b)(6) 2008 - patient underwent left inguinal nerve block.(b)(6) 2010 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with the implant of ventralex mesh (device #5).Per operative notes, ¿some intense scarring of small bowel was taken down.A piece of ventralex mesh (device #5) was placed and sutured." (b)(6) 2011 - patient had pain and was diagnosed with left mid abdominal hernia, multiple incisional hernia with small bowel and upper abdominal chronically incarcerated hernia with transverse colon thereby underwent open repair with the partial removal of ventralex mesh (device #5) and implant of sepramesh ip (device #6).Per operative notes, ¿large amount of small bowel adherent on the back of the dermis was taken down.There was small bowel loop densely adherent to the previous ventralex mesh (device #5) was debrided off the bowel and abdominal wall.The small patch of mesh was left on the loop of bowel.The separate fascial defect in the left mid abdomen was acutely incarcerated, closed with suture.Then, sepramesh ip (device #6) was placed and sutured.¿ (b)(6) 2016 - patient was diagnosed with ventral hernia and small bowel obstruction thereby underwent open repair with the removal of mesh (device #6) and implant of ventrio st mesh (device #7).Per operative notes, ¿the midline scar was excised, and sepramesh ip mesh (device #6) noted beneath scar was dissected out of the abdominal wall.The small bowel from loops of another small bowel were dissected.A ventrio st mesh (device #7) was used with a seprafilm coating was placed into the abdominal cavity directly on the underlying omentum and sutured.¿ (note: there was no information provided for the bard flat mesh (device #1) and bard flat mesh (device #2) in the provided medical records.).Attorney alleges that the patient had bowel obstruction, nerve damage, pain, hernia recurrence and infection.It was also alleged that the patient had multiple small bowel loops incarcerated in separate small patches of fascial defects and chronic abdominal pain.
Additional Manufacturer Narrative
Based on the information received, no conclusions can be made.Per medical records review, about 5 years 5 months post implant of sepramesh ip, patient was diagnosed with hernia recurrence, obstruction and scar tissue.The instructions-for-use supplied with the device list hernia recurrence as a possible complication.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Note, the manufacturing date (15-nov-2010) is considered to be a best estimate.This emdr represents the bard/davol sepramesh ip (device #6).Additional supplemental emdr's were submitted to represent the bard flat mesh (device #1, #2 & #4) and bard/davol mesh ¿ ventralex (device #5).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.; 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: 21536168
• Report Number: 1213643-2025-090127
• Device Sequence Number: 20767238
• Product Code: FTL
• UDI-Device Identifier: 00801741031830
• UDI-Public: (01)00801741031830(17)121128(10)HUUK0446
• 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: 2011
• 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): 03/06/2025

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: 11/28/2012
• Device Catalogue Number: 5959812
• Device Lot Number: HUUK0446
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2010
• 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: 51 YR
• Patient Sex: Male