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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND CO. SYRINGE SYRINGE, PISTON

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ELI LILLY AND CO. SYRINGE SYRINGE, PISTON Back to Search Results
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problems Hair Loss (1877); Memory Loss/Impairment (1958); Overdose (1988); Renal Failure (2041); Scar Tissue (2060); Sepsis (2067); Coma (2417); Confusion/ Disorientation (2553); Fluid Discharge (2686)
Event Date 01/20/2018
Event Type  Injury  
Event Description
Reporter stated that when she was trying to administer medication from the prefilled injector, something snapped inside the device and emptied 23 days' worth of medication all at once. Reporter contacted poison control people and stayed home. Reporter said the only thing she witnessed was amber like fluid coming through her bottom. As days went by, the reporter started having symptoms like, confusion, getting sick, sepsis, renal failure, small bowel obstruction, hair loss and ended up in the icu from a coma. She also suffered from memory loss and did not remember anything for about 12 days while in hospital. She said drs were able to reverse most of her conditions except the bowel obstruction issue. Late in (b)(6) she ended up again in er for the bowel obstruction issue and had surgeries to finally take care of the problem. All in all, she had 14 surgeries, 8 of them were abdominal. She also had scar tissues from all the surgeries. She was also saying there is no instructions with the medication packets that explains what the overdose amount is and what to do in the event of an overdose.
 
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Brand NameSYRINGE
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
ELI LILLY AND CO.
MDR Report Key8032448
MDR Text Key126110511
Report NumberMW5081000
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 11/01/2018 Patient Sequence Number: 1
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