MAUDE Adverse Event Report: GENZYME CORPORATION SEPRAMESH IP SURGICAL MESH

Model Number 5959812

Device Problem Defective Device (2588)

Patient Problems Pain (1994); Hernia (2240); Disability (2371)

Event Date 01/22/2011

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event. Based on the information provided, it was reported that the patient experienced hernia recurrence. Recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication. If additional event and/or evaluation information is obtained, a follow up mdr will be submitted. Not returned to manufacturer.

Event Description

The following was reported to davol by the patient's attorney: (b)(6) 2007 - the patient underwent surgery for repair of an incisional hernia. A bard/davol sepramesh ip, (b)(4), lot number 07npo56 was implanted to repair the hernia defect. (b)(6) 2011 - the patient underwent an additional surgery to remove the sepramesh ip, which allegedly failed, and repair the recurrent hernia. The attorney alleges the patient has suffered and will continue to suffer pain and was injured severely and permanently.

• 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: steven figueroa ; 100 crossings blvd.; warwick, RI 02886 ; 4018258460
• MDR Report Key: 7155014
• MDR Text Key: 96057818
• Report Number: 1213643-2017-01142
• Device Sequence Number: 1
• Product Code: FTL
• 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: consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

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

• Device Model Number: 5959812
• Device Catalogue Number: 5959812
• Device Lot Number: 07NP056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/29/2017 Patient Sequence Number: 1