MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ZIPSEAL 16 SURGICAL SKIN CLOSURE KIT, 5/PKG; WOUND DRESSING KIT

Model Number	PS1163
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Blister (4537)
Date of Event	09/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 1 event was reported for this quarter.Product return status: 1 device investigation type has not yet been determined.Additional information: 1 device was labeled for single-use.1 device was not reprocessed or reused.
Event or Problem Description
This report summarizes 1 malfunction event in which the device reportedly caused a tissue reaction with the patient.1 event which had a mild injury, illness or impairment which can be treated with minimal or no intervention.
Event or Problem Description
This report summarizes 1 malfunction event in which the device reportedly caused a tissue reaction with the patient.1 event which had a mild injury, illness or impairment which can be treated with minimal or no intervention.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: 1 previously reported event is included in this follow-up record.Product return status" 1 device was not available for evaluation.H3 other text : device discarded.

• Brand Name: ZIPSEAL 16 SURGICAL SKIN CLOSURE KIT, 5/PKG
• Common Device Name: WOUND DRESSING KIT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10748482
• Report Number: 3009673389-2020-00003
• Device Sequence Number: 19111115
• Product Code: MCY
• UDI-Device Identifier: 00853114007225
• UDI-Public: 00853114007225
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: PS1163
• Device Catalogue Number: PS1163
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 01/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1