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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO T4 ZIPPER TOGA, L/XL; GOWN, SURGICAL
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STRYKER INSTRUMENTS-KALAMAZOO T4 ZIPPER TOGA, L/XL; GOWN, SURGICAL Back to Search Results
Catalog Number 0400820000
Device Problems Material Integrity Problem (2978); Material Split, Cut or Torn (4008)
Patient Problem No Patient Involvement (2645)
Event Date 05/02/2018
Event Type  malfunction  
Event Description
It was reported that during inspection conducted at the user facility prior to the start of a surgical procedure, the outer coating on the front and sleeves of the gown appears to have come away from the backing material, as well as thinning and tearing of the outer layer.There was no patient involvement, no delay, no medical intervention, and no adverse consequences with this event.
 
Event Description
It was reported that during inspection conducted at the user facility prior to the start of a surgical procedure, the outer coating on the front and sleeves of the gown appears to have come away from the backing material, as well as thinning and tearing of the outer layer.There was no patient involvement, no delay, no medical intervention, and no adverse consequences with this event.
 
Event Description
It was reported that during inspection conducted at the user facility prior to the start of a surgical procedure, the outer coating on the front and sleeves of the gown appears to have come away from the backing material, as well as thinning and tearing of the outer layer.There was no patient involvement, no delay, no medical intervention, and no adverse consequences with this event.
 
Manufacturer Narrative
Device evaluation: device was not returned.
 
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Brand Name
T4 ZIPPER TOGA, L/XL
Type of Device
GOWN, SURGICAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key7556916
MDR Text Key109746091
Report Number0001811755-2018-01025
Device Sequence Number1
Product Code FYA
UDI-Device Identifier34546540152689
UDI-Public34546540152689
Combination Product (y/n)N
PMA/PMN Number
K070078
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 12/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0400820000
Device Lot Number17072041
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/21/2018
Date Manufacturer Received11/30/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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