MAUDE Adverse Event Report: SYNOVIS SURGICAL INNOVATIONS PERI-GUARD; MESH, SURGICAL

Catalog Number PC0608SNBIO

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received and the evaluation was completed to investigate the reported issue.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Visual inspection revealed a brown hair on the rough side of the patch, approximately 8.1cm in length.The reported condition was verified.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a hair was discovered inside the package of a peri-guard.This was found during setup, there was no patient involvement.No additional information is available.

• Brand Name: PERI-GUARD
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave. w; saint paul MN 55144
• Manufacturer (Section G): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave. w; saint paul MN 55144
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5516920
• MDR Text Key: 40936325
• Report Number: 1416980-2016-05765
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983162
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/17/2019
• Device Catalogue Number: PC0608SNBIO
• Device Lot Number: SPCE114-07G0004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2016
• Date Manufacturer Received: 02/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1