MAUDE Adverse Event Report: ZIPLINE INDUSTRIES, INC. ZIP SURGICAL SKIN CLOSURE; TAPE AND BANDAGE, ADHESIVE

Device Problem Output Problem (3005)

Patient Problem Wound Dehiscence (1154)

Event Date 03/12/2019

Event Type  malfunction  

Event Description

Zip surgical skin closure failed on post op day 1 on total knee arthroplasty.Required return to surgery for traditional wound closure.Zip surgical skin closure - (b)(6) 2019.

• Brand Name: ZIP SURGICAL SKIN CLOSURE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): ZIPLINE INDUSTRIES, INC. ; campbell CA 95008
• MDR Report Key: 8444106
• MDR Text Key: 139685366
• Report Number: MW5085080
• Device Sequence Number: 0
• Product Code: KGX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Age: 57 YR
• Patient Weight: 128