MAUDE Adverse Event Report: GENZYME CORPORATION SEPRAMESH IP; SURGICAL MESH

Catalog Number 5959360

Device Problems Defective Device (2588); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Laceration(s) (1946); Pain (1994); Disability (2371)

Event Date 03/30/2011

Event Type  Injury  

Manufacturer Narrative

To date, limited information has been provided.Based on the limited information available at this time, we are unable to determine to what extent, if any, the bard device may have caused or contributed to the events as alleged.Regarding adhesions, the warning section of the ifu states "there may be a possibility for adhesion formation when the prosthesis is placed in direct contact with the bowel or viscera.If additional information is obtained, a supplemental mdr will be submitted.The information provided by bard 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 bard.Not returned.

Event Description

It is alleged by the patients attorney that on (b)(6) 2009, the patient underwent surgery for repair of an incisional type hernia.As reported, a bard/davol sepramesh ip, reference number 5959360, lot number wbsls234 was implanted to repair the hernia defect.It is alleged that on (b)(6) 2011, the patient underwent an additional surgery to remove the abdominal wall mesh, repair of bladder wall laceration, and lysis of adhesions.As alleged, the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the alleged defective separmesh ip.

Event Description

It is alleged by the patients attorney that on (b)(6) 2009, the patient underwent surgery for repair of an incisional type hernia.As reported, a bard/davol sepramesh ip, reference number (b)(4) , lot number wbsls234 was implanted to repair the hernia defect.It is alleged that on (b)(6) 2011, the patient underwent an additional surgery to remove the abdominal wall mesh, repair of bladder wall laceration, and lysis of adhesions.As alleged, the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the alleged defective separmesh ip.Addendum per additional information provided: on (b)(6) 2009 - patient was diagnosed with incisional hernia thereby underwent laparoscopic repair with the implant of sepramesh ip.Per operative notes, ¿hernia defect was found, and a mesh repair was performed, securing the sepramesh ip inferiorly, cooper's ligament superomedially to conjoined tendons, superolaterally to transversalis fascia and the peritoneum was then tacked over the mesh.¿ on (b)(6) 2011 - patient was diagnosed with pain, bladder wall adhesions to abdominal wall mesh with retraction and invasion of bladder wall thereby underwent laparoscopic to open repair with the removal of old mesh.Per operative notes, ¿mesh in the left lower quadrant of the abdominal wall was identified with copious omental adhesions and bladder adhesions to the mesh.Adhesions were lysed.The mesh was grasped but was not easily dissected away from the anterior abdominal wall.The 3 tacks were palpable within the adherent tissue to the caudal edge of the mesh was dissected from its adhesions, the adjoining tacks were left within the residual tissue attached to the mesh and the mesh was excised.¿ attorney alleges that the patient had adhesions, infection, mesh migration, other organ perforation, pain and emotional injuries.It was also alleged that the patient underwent removal surgery.

Manufacturer Narrative

To date, limited information has been provided.Based on the limited information available at this time, we are unable to determine to what extent, if any, the bard device may have caused or contributed to the events as alleged.Regarding adhesions, the warning section of the ifu states "there may be a possibility for adhesion formation when the prosthesis is placed in direct contact with the bowel or viscera.If additional information is obtained, a supplemental mdr will be submitted.Addendum: this supplemental emdr is submitted to document additional information provided.Based on the additional information received, there is no change to the initial determination, no conclusions can be made.Per medical records review, about 2 years post implant of sepramesh ip, patient was diagnosed with adhesions, pain thereby underwent repair with mesh removal.A review of the manufacturing records was performed and found that the lot was manufactured to specification.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.H3 other text : not returned.

• Brand Name: SEPRAMESH IP
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): GENZYME CORPORATION; 80 new york ave; framingham MA 01701
• Manufacturer (Section G): GENZYME CORPORATION; 80 new york ave; framingham MA 01701
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 7153953
• MDR Text Key: 96018661
• Report Number: 1213643-2017-01137
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031809
• UDI-Public: (01)00801741031809
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2010
• Device Catalogue Number: 5959360
• Device Lot Number: WBSLS234
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 50 KG