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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURE-T® PARADIGM®; CONTACT DETACH G29 80/10 PCC
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SURE-T® PARADIGM®; CONTACT DETACH G29 80/10 PCC Back to Search Results
Lot Number 5198468
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Tissue Damage (2104)
Event Type  malfunction  
Event Description
Unomedical reference number (b)(4).Event occurred in the united states.The patient's father reported that in one of the sets, after having lunch, the patient's blood glucose level started going up (550 mg/dl) and the father replaced his set.When the patient's father took the old set off, the entire needle broke off into the patient's body and it stayed in it.Two days before the event, the first set was inserted, and his father gave him a manual injection.On the day of the event, the patient had to go to the hospital to get the needle removed.He visited the emergency room and was admitted to the hospital with blood glucose level around 120 mg/dl.The set's insertion location was at the upper buttock area.The infusion set had been in use for two days.The patient underwent surgery as medical treatment to remove the needle from the body.On the day of this report, it was stated that the needle was not in his body.No further information available.
 
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Brand Name
SURE-T® PARADIGM®
Type of Device
CONTACT DETACH G29 80/10 PCC
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key8703243
MDR Text Key148152475
Report Number3003442380-2019-01544
Device Sequence Number1
Product Code FPA
UDI-Device Identifier05705244006034
UDI-Public05705244006034
Combination Product (y/n)N
PMA/PMN Number
K160648
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date08/01/2020
Device Lot Number5198468
Date Manufacturer Received04/17/2019
Type of Device Usage N
Patient Sequence Number1
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