MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP ZIP 16 SURGICAL SKIN CLOSURE DEVICE; TAPE AND BANDAGE, ADHESIVE

Catalog Number	PS1160
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033); Dysphasia (2195)
Date of Event	09/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : device discarded.
Event or Problem Description
It was reported that the zip device was used to close the wound after the patient's total knee replacement.The zip was removed from the patient three days early due to an allergic reaction.Patient developed a rash on the wound site and was having difficulty swallowing.Attempts are being made to obtain additional information about the adverse consequences and treatment.
Additional Manufacturer Narrative
Additional information: b5, d4 h3 other text : device discarded.
Event or Problem Description
It was reported that the zip device was used to close the wound after the patient's total knee replacement.The zip was removed from the patient three days early due to an allergic reaction.Patient developed a rash on the wound site, had itching, and was having difficulty swallowing.

• Brand Name: ZIP 16 SURGICAL SKIN CLOSURE DEVICE
• Common Device Name: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 17914844
• Report Number: 3015967359-2023-02095
• Device Sequence Number: 6653445
• Product Code: KGX
• UDI-Device Identifier: 10865379000016
• UDI-Public: 10865379000016
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: PS1160
• Device Lot Number: 0000234200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2023
• Supplement Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown