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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 07/29/2020
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
Additional information: b5, d4 h3 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 Key10479658
Report Number0001811755-2020-02287
Device Sequence Number2445332
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) 04/20/2021
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 Manufacturer04/16/2021
Initial Report FDA Received Date09/01/2020
Supplement Report FDA Received Date04/20/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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