MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ZIP 24 SURGICAL SKIN CLOSURE DEVICE; TAPE AND BANDAGE, ADHESIVE

Catalog Number	PS1240
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	04/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Currently, the health impact and potential medical intervention are unknown.This report is being filed in an abundance of caution based on an initial assessment of the event as reported.
Event or Problem Description
The user facility reported that the device was delaminating skin upon removal.  attempts are being made to obtain additional information about the event; no further information has been received.
Additional Manufacturer Narrative
H3 other text: device discarded.
Event or Problem Description
The user facility reported that the device was delaminating skin upon removal.  patient was referred to a dermatologist where a steroid was given to help heal the delamination.However upon a later visit to the surgeon the steroid was not helping and the reaction had spread so the surgeons brought him in for an additional wash out procedure and re-closed the wound.The patient was seen after this and seemed to be healing normally.

• Brand Name: ZIP 24 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 Key: 11812040
• Report Number: 3015967359-2021-00836
• Device Sequence Number: 17078344
• Product Code: KGX
• UDI-Device Identifier: 10853114007192
• UDI-Public: 10853114007192
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2021

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: PS1240
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention