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

Catalog Number PC1016NBIO

Device Problem Product Quality Problem (1506)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the temperature indicator of a peri-guard had turned white.This event was discovered prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PERI-GUARD
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): SYNOVIS SURGICAL INNOVATIONS; saint paul MN
• Manufacturer (Section G): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave w; saint paul MN 55114
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7737540
• MDR Text Key: 115675775
• Report Number: 1416980-2018-04792
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00085412530604
• UDI-Public: (01)00085412530604
• 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,Followup
• Report Date: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/10/2022
• Device Catalogue Number: PC1016NBIO
• Device Lot Number: SP17J26-1255578
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2018
• 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: N
• Patient Sequence Number: 1