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U.S. Department of Health and Human Services

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

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SYNOVIS SURGICAL INNOVATIONS PERI-STRIP MESH, SURGICAL Back to Search Results
Catalog Number PSD6006UV
Device Problem Device Emits Odor (1425)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). (b)(6). This event occurred sometime in (b)(6) 2016. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the foam of a peri-strip was all wet and had a strange odor this was identified after the product was received. There was no patient involvement. No additional information is available.
 
Manufacturer Narrative
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.
 
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Brand NamePERI-STRIP
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
SYNOVIS SURGICAL INNOVATIONS
saint paul MN
Manufacturer (Section G)
SYNOVIS SURGICAL INNOVATIONS
2575 university ave. w
saint paul MN 55144
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key6045580
MDR Text Key58019585
Report Number1416980-2016-16479
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K041669
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/23/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/20/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date01/27/2019
Device Catalogue NumberPSD6006UV
Device Lot NumberSP16G06-1165188
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 Received11/22/2016
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

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