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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PARIS CHILD CARE PLANT GOODNIGHTS UNDERPANTS; INCONTINENCE GARMENT
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PARIS CHILD CARE PLANT GOODNIGHTS UNDERPANTS; INCONTINENCE GARMENT Back to Search Results
Model Number GOODNIGHTS FOR BOYS
Device Problem Insufficient Information (3190)
Patient Problems Fungus (1872); Rash (2033); Caustic/Chemical Burns (2549)
Event Date 01/01/2014
Event Type  Injury  
Event Description
This is non-us event.The event occurred in (b)(6).The consumer stated that her son developed a chemical-burn like rash on his back and backside after underpant usage.He visited his physician and was prescribed a fungal cream.
 
Manufacturer Narrative
Device history record could not be reviewed as lot code was not provided by the consumer.Information from this incident will be included in our product complaint and mdr trend analysis.Consumer had not returned unused product for evaluation at the time of this report.
 
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Brand Name
GOODNIGHTS UNDERPANTS
Type of Device
INCONTINENCE GARMENT
Manufacturer (Section D)
PARIS CHILD CARE PLANT
2466 farm road 137
paris TX 75460
Manufacturer Contact
charnelle thomas
1400 holcomb bridge rd.
roswell, GA 30076
6783526031
MDR Report Key3953317
MDR Text Key4646305
Report Number1650783-2014-00002
Device Sequence Number1
Product Code EYQ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Invalid Data,Consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/24/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberGOODNIGHTS FOR BOYS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/24/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age2 YR
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