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

Catalog Number	5959360
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001); Migration (4003)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240); Insufficient Information (4580)
Date of Event	04/03/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient"; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents the bard/davol sepramesh ip (device #1).Additional emdrs were submitted to represent the bard/davol ventralex st (device #2), bard/davol ventrio st (device #3), bard/davol phasix mesh (device #4) and the bard/davol xenmatrix ab (device #5).Should additional information be provided, a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol sepramesh composite ip on (b)(6) 2010, ventralex st and ventrio st on (b)(6) 2014, phasix mesh and xenmatrix ab on (b)(6) 2016.As reported, the patient is making a claim for an adverse patient outcome against all devices.It is alleged that the patient sustained injuries on (b)(6) 2016.Attorney alleges general allegations for ¿past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is also alleged that the patient experienced emotional distress and the device was defective.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient"; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct the date of event.Based on the additional information received, there is no change to initial determination, no conclusions can be made.Per medical records review, about 3 years 8 months post implant of sepramesh ip, patient was diagnosed with hernia recurrence, adhesions and pain thereby underwent repair with removal of mesh.The instructions-for-use supplied with the device lists hernia recurrence, adhesions and pain as possible complications.Note, the manufacturing date (15-mar-2010) is considered to be a best estimate.This supplemental emdr represents sepramesh ip (device #1).Additional supplemental emdr' s were submitted to represent ventralex st (device #2), ventrio st (device #3), phasix mesh (device #4) and the xenmatrix ab (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.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol sepramesh composite ip on (b)(6) 2010, ventralex st and ventrio st on (b)(6) 2014, phasix mesh and xenmatrix ab on (b)(6) 2016.As reported, the patient is making a claim for an adverse patient outcome against all devices.It is alleged that the patient sustained injuries on (b)(6) 2016.Attorney alleges general allegations for ¿past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2010 - patient was diagnosed with large recurrent ventral umbilical hernia thereby underwent open repair with the implant of sepramesh ip (device #1).Per operative notes, ¿the lipoma of the cord was excised.A sepramesh ip (device #1) was placed and secured to the fascia using sutures.¿ (b)(6) 2014 - patient was diagnosed with recurrent complex ventral hernia and pain thereby underwent open repair with explant of sepramesh ip (device #1) and implant of ventralex st (device #2) and ventrio st (device #3).Per operative notes, ¿sepramesh ip (device #1) was appeared to be loose and it was excised.An another hernia defect was identified between the two layers of sepramesh ip (device #1) and all adhesions were taken down.A medium size ventralex st mesh (device #2) was placed and secured by sutures.Then a ventrio st (device #3) was placed and secured by sutures.¿ (b)(6) 2015 - patient was diagnosed with chronic abdominal pain thereby underwent laparoscopic repair.Per operative notes, ¿all adhesions were taken down and the bowel appeared to be intact.¿ (there were no visualization/mention of sepramesh ip (device #1), ventralex st (device #2) and ventrio st (device #3).(b)(6) 2016 - patient was diagnosed with mesh infection, purulent discharge and abdominal pain thereby underwent open repair with explant of ventralex st (device #2), ventrio st (device #3) and implant of phasix mesh (device #4), xenmatrix ab (device #5).Per operative notes, ¿both ventralex st (device #2) and ventrio st (device #3) were removed.All adhesions were taken down in the anterior abdominal wall.Then a xenmatrix ab (device #5) was placed underlay and secured to the anterior abdominal wall using sutures.Then a phasix mesh (device #4) was placed overlay and anchored to the abdominal wall using sutures.¿ (b)(6) 2016 to (b)(6) 2017 - patient complains of abscess and abdominal pain.Attorney alleges that the patient had abscess, adhesions, bowel obstruction, infection, mesh migration, mesh shrinkage, pain, hernia recurrence, seroma and emotional injuries.

• 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: 12097827
• Report Number: 1213643-2021-05434
• Device Sequence Number: 11804533
• Product Code: FTL
• UDI-Device Identifier: 00801741031809
• UDI-Public: (01)00801741031809(17)120328(10)HUUC0449
• 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: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2024

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: 03/28/2012
• Device Catalogue Number: 5959360
• Device Lot Number: HUUC0449
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2021
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2010
• 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: Disability; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 99 KG