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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: R82 A/S CROCODILE

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R82 A/S CROCODILE Back to Search Results
Model Number SIZE 2
Device Problem Device Slipped (1584)
Patient Problem Sensitivity of Teeth (2427)
Event Date 12/16/2014
Event Type  malfunction  
Event Description
A child was in a crocodile 2 when the seat failed to hold in place.The child chipped a tooth.
 
Manufacturer Narrative
(b)(4) is waiting for the product to be returned for eval.
 
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Brand Name
CROCODILE
Type of Device
CROCODILE
Manufacturer (Section D)
R82 A/S
parallelvej 3
gedved 8751
DA  8751
Manufacturer Contact
kent rasmussen
parallelvej 3
gedved 8751
DA   8751
579685888
MDR Report Key4495617
MDR Text Key5334113
Report Number3001657382-2014-00011
Device Sequence Number1
Product Code ITJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 01/13/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberSIZE 2
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/14/2015
Distributor Facility Aware Date12/17/2014
Event Location Home
Date Report to Manufacturer12/17/2014
Initial Date Manufacturer Received 12/17/2014
Initial Date FDA Received01/14/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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