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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Skin Burning Sensation (4540); Skin Inflammation/ Irritation (4545)

Event Date 10/06/2022

Event Type  Injury  

Event Description

The patient reported that the zip device caused a reaction on her skin that was observed upon removal.There was a painful redness that remained on the skin for a month before fading.Used over the counter ointment to help treat the reaction.

Manufacturer Narrative

Scrapped.

• 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: 16354178
• MDR Text Key: 309300899
• Report Number: 3015967359-2023-00395
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 10865379000016
• UDI-Public: 10865379000016
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: PS1160
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/18/2022
• 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): Other