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

Catalog Number PS1160

Device Problem Biocompatibility (2886)

Patient Problems Dysphagia/ Odynophagia (1815); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033); Dysphasia (2195)

Event Date 09/30/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : device discarded.

Event 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.

Manufacturer Narrative

Additional information: b5, d4 h3 other text : device discarded.

Event 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
• Type of Device: 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
• MDR Text Key: 325418210
• Report Number: 3015967359-2023-02095
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 10865379000016
• UDI-Public: 10865379000016
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: PS1160
• Device Lot Number: 0000234200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/03/2023
• Initial Date FDA Received: 10/11/2023
• Supplement Dates Manufacturer Received: 12/08/2023
• Supplement Dates FDA Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention