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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EQUIDYNE SYSTEMS INJEX-30 NEEDLELESS INSULIN INJECTOR

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EQUIDYNE SYSTEMS INJEX-30 NEEDLELESS INSULIN INJECTOR Back to Search Results
Model Number INJEX-30 AMPULE
Event Date 08/01/2005
Event Type  Other  
Event Description

I am using an injex-30 needleless injector for insulin. It has an ampule that holds and injects the insulin. This ampule shattered when i used it to inject 7 units of insulin resulting in minor cuts and a bruise about 4 inches across. I have had three of the ampules shatter in the past three weeks. This injector is supposed to inject from 5-30 units. I have contacted the mfr with little success in resolving the problem. The first time it happened i did not save the shattered ampule as i thought i had done something wrong, but when it happened two more times with the second resulting in serious bruising due to the plunger sticking out beyond the end of the ampule i did save those two.

 
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Brand NameINJEX-30
Type of DeviceNEEDLELESS INSULIN INJECTOR
Manufacturer (Section D)
EQUIDYNE SYSTEMS
san deigo CA *
MDR Report Key751543
Report NumberMW1036379
Device Sequence Number1
Product CodeKZE
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/17/2005
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/17/2005
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device MODEL NumberINJEX-30 AMPULE
Device Catalogue NumberP/N 100100
Device LOT Number3481A
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location Home
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 08/17/2005 Patient Sequence Number: 1
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