MAUDE Adverse Event Report: PARIS CHILD CARE PLANT GOODNIGHTS UNDERPANTS; INCONTINENCE GARMENT

Model Number GOODNIGHTS UNDERPANTS FOR GIRLS

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Fever (1858); Headache (1880); Inflammation (1932); Nausea (1970); Rash (2033); Staphylococcus Aureus (2058)

Event Date 01/18/2014

Event Type  Injury  

Event Description

The consumer stated that her daughter developed a boil, which had to be lanced, after underpant usage.She stated that her daughter began wearing goodnights underwear on (b)(6) 2014 and wore them for 2 nights.She developed 10 small spots on her buttocks which resembled red pimples.One of the spots developed into a boil that turned into a white pimple.She also stated that her daughter soon after developed fever, nausea and a headache.She stated that her daughter experienced the same event once before when she had a urinary tract infection.She gave her daughter motrin for the fever and applied a&d ointment to the spots.She visited her physician, who lanced the boil and tested it for (b)(6).Her physician prescribed sulfamethoxazole for 10 days.She indicated that doctor diagnosed her daughter with (b)(6) infection, but did not have the final mrsa results.

Manufacturer Narrative

Device history record is under review.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.

• 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 Key: 3637139
• MDR Text Key: 3988836
• Report Number: 1650783-2014-00001
• Device Sequence Number: 1
• Product Code: EYQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: GOODNIGHTS UNDERPANTS FOR GIRLS
• Device Lot Number: PA323515B0235
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 6 YR