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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DR. REDDY'S AUTO-INJECTOR; INJECTOR, PEN
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DR. REDDY'S AUTO-INJECTOR; INJECTOR, PEN Back to Search Results
Device Problems Failure to Deliver (2338); Defective Device (2588)
Patient Problem Insufficient Information (4580)
Event Date 01/01/2000
Event Type  malfunction  
Event Description
Patient called to report a product issue with his auto-injector he uses to deliver sumatriptan for severe headaches.Patient stated there are 2 to a box, and in early 2000 he experienced a product issue where the device would not deliver his medication.The issue happened with two auto-injectors that came in one box.Patient stated the devices were defective and explained he could have had an embolism since he saw air in the vial.Patient stated he contacted dr.(b)(6) for replacement devices and figured he would hear back within a couple weeks.Patient said he never heard anything back until a year and a half later he found out he would need to file a case in small claims court.Patient stated he was never told he needed to do that upfront when he first reported the product issue.Patient stated he then contacted an attorney and filed a suit in small claims court.Patient stated he suffers from a traumatic brain injury and depends heavily on this medication.Patient would like to bring more awareness to this issue and how it was handled.
 
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Brand Name
DR. REDDY'S AUTO-INJECTOR
Type of Device
INJECTOR, PEN
MDR Report Key12149788
MDR Text Key261236616
Report NumberMW5102454
Device Sequence Number1
Product Code NSC
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Is the Reporter a Health Professional? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age67 YR
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