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

Catalog Number	5959812
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001); Migration (4003)
Health Effect - Clinical Codes	Abdominal Pain (1685); Hernia (2240); Nodule (4551)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including permanent injury, hernia recurrence, mesh detachment, migration and subsequent surgical intervention for mesh removal.The instructions-for-use supplied with the device lists recurrence of hernia as a possible complication.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 a bard/davol sepramesh ip on (b)(6) 2009 for a hernia repair.It is alleged that further to implantation with the product, the patient suffered the development of abdominal pain, a large hypoechoic mass project inferior to the umbilicus, recurrent ventral hernias, mesh bulges, detachment and displacement of the left lateral aspect of the product, necessitating removal of the product.It is alleged that the patient has suffered injuries, losses and damages resulting from numerous defects in the product that create an unreasonably high risk of injury with severe permanent adverse health consequences.Attorney alleges that the patient experienced severe pain and suffering, including chronic pain.It is also alleged the patient was treated with a course of hospitalization, diagnostic imaging, revision surgery, serum testing, antibiotics, analgesics and rest.Attorney alleges that the patient will require further invasive repair surgery, physiotherapy, rehabilitation and will continue to require other forms of medical care.It is also alleged that the device was defective.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including permanent injury, hernia recurrence, mesh detachment, migration and subsequent surgical intervention for mesh removal.The instructions-for-use supplied with the device lists recurrence of hernia as a possible complication.Addendum: h.11: this is an addendum to the initial emdr submitted.This supplemental emdr is submitted to report the corrected manufacturing site.Updated fields: b4, g3, g6, h2, h10, h11 corrected field: g1 (manufacturing site) should additional information be provided, a supplemental emdr will be submitted.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.Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of a bard/davol sepramesh ip on (b)(6) 2009 for a hernia repair.It is alleged that further to implantation with the product, the patient suffered the development of abdominal pain, a large hypoechoic mass project inferior to the umbilicus, recurrent ventral hernias, mesh bulges, detachment and displacement of the left lateral aspect of the product, necessitating removal of the product.It is alleged that the patient has suffered injuries, losses and damages resulting from numerous defects in the product that create an unreasonably high risk of injury with severe permanent adverse health consequences.Attorney alleges that the patient experienced severe pain and suffering, including chronic pain.It is also alleged the patient was treated with a course of hospitalization, diagnostic imaging, revision surgery, serum testing, antibiotics, analgesics and rest.Attorney alleges that the patient will require further invasive repair surgery, physiotherapy, rehabilitation and will continue to require other forms of medical care.It is also alleged that the device was defective.

• 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
• MDR Report Key: 12322181
• Report Number: 1213643-2021-06864
• Device Sequence Number: 19908759
• Product Code: FTL
• UDI-Device Identifier: 00801741031830
• UDI-Public: (01)00801741031830
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K063739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2021

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 Catalogue Number: 5959812
• Device Lot Number: WBTCS031
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/22/2021
• Supplement Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 08/14/2021
• Supplement Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability
• Patient Age: 43 YR