MAUDE Adverse Event Report: SCANDINAVIAN HEALTH LTD. WHISPERJECT AUTOINJECTOR; INTRODUCER, SYRINGE NEEDLE

Health Effect - Clinical Code	Irritation (1941)
Type of Reportable Event	Serious Injury
Event or Problem Description
Spontaneous report from patient: when patient went to inject med, not all of med was injected when he used whisperject device ((b)(6) did not dispense the device), he had irritation on his skin at the injection site that he has not experienced prior after device seemed to fail.Unknown if he still has the device on hand.No further information available.Device not provided by (b)(6), but we will be replacing device, made (b)(6) to send new whisperject.Reported to (b)(6) by pt/caregiver.

• Brand Name: WHISPERJECT AUTOINJECTOR
• Common Device Name: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): SCANDINAVIAN HEALTH LTD.
• MDR Report Key: 10132782
• Report Number: MW5094891
• Device Sequence Number: 16374914
• Product Code: KZH
• Combination Product (Y/N): Y
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2020

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?: Yes
• Operator of Device: No Information
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/08/2020
• Patient Sequence Number: 1