MAUDE Adverse Event Report: ZIPLINE MEDICAL ZIPSEAL 24 SURGICAL SKIN CLOSURE KIT; TAPE-BASED WOUND CLOSURE & SKIN ADHESIVE

Model Number	PS1243
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Insufficient information has been provided to allow for investigation.No photographic images were provided to the zipline territory manager to assist in the investigation.Requests for additional information were delivered, but no response was received.
Event or Problem Description
Following completion of a total knee arthroplasty, the surgeon performed surface closure with a zipseal 24 convenience kit, which consists of a zipline zip 24 surgical skin closure device and cardinal health liquiband octyl 0.8ml skin adhesive.Per the zipline territory manager, the physician reported that the patient developed a blister under the zip device.The surgeon chose to re-admit the patient and perform irrigation and debridement of the blister.

• Brand Name: ZIPSEAL 24 SURGICAL SKIN CLOSURE KIT
• Common Device Name: TAPE-BASED WOUND CLOSURE & SKIN ADHESIVE
• Manufacturer (Section D): ZIPLINE MEDICAL; 747 camden ave.; suite a; campbell, ca
• MDR Report Key: 9759446
• Report Number: 3009673389-2020-00001
• Device Sequence Number: 14067647
• Product Code: MCY
• UDI-Device Identifier: 00853114007232
• UDI-Public: (01)00853114007232(17)200628(10)1917801
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: ENFORCEMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2019

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 Expiration Date: 06/28/2020
• Device Model Number: PS1243
• Device Catalogue Number: PS1243
• Device Lot Number: 1917801
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 02/26/2020
• 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