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

Catalog Number 5959680

Device Problem Insufficient Information (3190)

Patient Problems Adhesion(s) (1695); Hernia (2240)

Event Type  Injury  

Manufacturer Narrative

Based on the information available at this time, no definitive conclusions can be made. A review of the manufacturing records was performed and found that the lot was manufactured to specification. Recurrence and adhesion are both known inherent risks of the surgery and are listed in the adverse reaction section of the ifu as possible complications. The operative report from the implant procedure was provided confirming the implant of a sepramesh ip device. A video alleged to be of the revision procedure was provided for review. There was no visualization of a sepramesh ip in the video, nor did it show any mesh attached to the colon. A mesh was observed in the video, however it was not a sepramesh ip device. It is not known if the patient was implanted with other mesh products. 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 reported that in 2013 the patient was implanted with a bard sepramesh ip to repair an abdominal hernia. As reported three years later the patient underwent an additional procedure due to a recurrence of hernia. During this procedure it is reported that the mesh was found to be attached to the colon.

• Brand Name: SEPRAMESH IP
• Type of Device: 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: laura berg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 5939829
• MDR Text Key: 54335417
• Report Number: 1213643-2016-00433
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (Y/N): N
• PMA/PMN Number: K063739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG

Reporter Occupation

• Type of Report: Initial
• Report Date: 08/15/2016

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 09/09/2016
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 08/28/2014
• Device Catalogue Number: 5959680
• Device LOT Number: HUWH1086
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: Hospital
• Date Manufacturer Received: 08/15/2016
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 08/30/2012
• 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: 09/09/2016 Patient Sequence Number: 1