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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PERI-STRIPS MESH, SURGICAL

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BAXTER HEALTHCARE CORPORATION PERI-STRIPS MESH, SURGICAL Back to Search Results
Catalog Number PSDA60ECH
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Event Date 06/26/2020
Event Type  Injury  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a peri-strip secure grip was "gelled over" and the plastic strip (liner) was not removed from the secure grip; the peri-strip was applied onto the stapler. It was further reported that the surgeon stapled with the plastic strip still on the peri-strip. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
 
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Brand NamePERI-STRIPS
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
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 Key10302664
MDR Text Key199702448
Report Number1416980-2020-04144
Device Sequence Number1
Product Code FTM
UDI-Device Identifier00085412658803
UDI-Public(01)00085412658803
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 09/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/09/2021
Device Catalogue NumberPSDA60ECH
Device Lot NumberSP20E22-1452912
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2021
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: 07/21/2020 Patient Sequence Number: 1
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