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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ZIP 16 SURGICAL SKIN CLOSURE DEVICE; TAPE AND BANDAGE, ADHESIVE
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STRYKER INSTRUMENTS-KALAMAZOO ZIP 16 SURGICAL SKIN CLOSURE DEVICE; TAPE AND BANDAGE, ADHESIVE Back to Search Results
Catalog Number PS1160
Medical Device Problem Codes Patient-Device Incompatibility (2682); Biocompatibility (2886)
Health Effect - Clinical Codes Reaction (2414); Blister (4537)
Date of Event 07/24/2020
Type of Reportable Event Malfunction
Event or Problem Description
The user facility reported that blisters formed under the device after a procedure.The blisters cracked and healed and the user facility reported no further issue after they healed.
 
Additional Manufacturer Narrative
Device discarded.
 
Event or Problem Description
The user facility reported that blisters formed under the device after a procedure.The blisters cracked and healed and the user facility reported no further issue after they healed.
 
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Brand Name
ZIP 16 SURGICAL SKIN CLOSURE DEVICE
Common Device Name
TAPE AND BANDAGE, ADHESIVE
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key10482173
Report Number0001811755-2020-02288
Device Sequence Number4060270
Product Code KGX
UDI-Device Identifier10865379000016
UDI-Public10865379000016
Combination Product (Y/N)N
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 02/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue NumberPS1160
Device Lot Number0000142164
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/05/2020
Supplement Date Received by Manufacturer08/05/2020
Initial Report FDA Received Date09/02/2020
Supplement Report FDA Received Date02/12/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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