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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 Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/12/2021
Event Type  Injury  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported two (2) peri-strips were placed on a patient "with the adhesive covering still on". The event occurred in the operating room and was further described as ¿the technician placed glue on top of the adhesive liner instead of removing the liner. A different technician switched in midway through the procedure. The surgeon then placed the peri-strips onto the patient¿s abdomen in that condition. The technician then noticed that the per-strips looked different and realized the error; however, the procedure was completed with the per-strips left in with liners attached as the surgeon stated they did not have a lot of room to go back and remove the liners. At the time of the follow up the liners were in the patient¿. There was no 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 
2242702068
MDR Report Key12416314
MDR Text Key269612443
Report Number1416980-2021-05403
Device Sequence Number1
Product Code FTM
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K192615
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 12/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberPSDA60ECH
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/30/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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: 09/02/2021 Patient Sequence Number: 1
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