MAUDE Adverse Event Report: SCANDINAVIAN HEALTH LTD / MYLAN PHARMACEUTICALS INC. 1-WHISPERJECT; INTRODUCER, SYRINGE NEEDLE

Device Problem Use of Device Problem (1670)

Patient Problem Scarring (2061)

Event Type  Injury  

Event Description

Reporter of product complaint: patient.Summary of product complaint: the whisperject - it's messing up, it sometimes leaves scaring on his arm date of occurrence: unknown.Was the product taken/administered? administered.Can manufacturer call patient for follow up? yes.Can manufacturer arrange for product pick up? yes.The lot number is unknown because the patient was not able to locate item.

• Brand Name: 1-WHISPERJECT
• Type of Device: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): SCANDINAVIAN HEALTH LTD / MYLAN PHARMACEUTICALS INC.
• MDR Report Key: 10559716
• MDR Text Key: 207902649
• Report Number: MW5096752
• Device Sequence Number: 1
• Product Code: KZH
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1