THERMACARE HEATWRAPS, NECK, SHOULDER & WRIST (NOT APPLICABLE) WRAP 1APPLIC

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-06-04 for THERMACARE HEATWRAPS, NECK, SHOULDER & WRIST (NOT APPLICABLE) WRAP 1APPLIC manufactured by Wyeth Consumer Healthcare.

Event Text Entries

[20843315] Third degree burns on her neck [burns third degree]. Blister was open and the skin was gone [burns second degree]. Peeling skin [skin exfoliation]. Redness [erythema]. Impetigo [impetigo]. Pus [wound secretion]. Constant sharp/stabbing pain [pain]. Would wear one wrap for 12 hours, take a break and then wear another [device misuse]. Case description: initial information was received from a consumer and additional information was received in the form of medical records and a consumer questionnaire. The patient is a female who used thermacare neck, shoulder and wrist heatwrap (lot # 8214u018s, expiration date 07/2011) for neck pain for 4 days in 2009. It was reported that the patient wore the wrap against her skin and that she would wear one wrap for 12 hours, take a two hour break and then wear another (device misuse/device misuse). At some point, during those three days, the patient experienced several second degree burns. There was no blistering, but she did notice peeling skin (skin exfoliation/skin exfoliation). The patient was taken to the hospital in the next day after the use, where she was diagnosed with a second degree burn. Treatment included an unspecified antibiotic cream and a tetanus shot. The patient was advised to change her dressing three times a day and to keep a close eye for any signs of infection. The patient has not recovered from the events. Of note, the patient was an experienced user who had previously used the back wraps without incident. No skin creams, ointments or oils were used by the patient. Consumer questionnaire revealed that the patient wore the wrap directly against her skin for five to six hours for three days. The patient denied sleeping with the wrap on and heating or re-heating the wrap in a microwave. The wrap was not worn on broken skin and the area was not bruised or swollen prior to application. The patient checked the skin frequently and did not detect any irritation or burning during use. The questionnaire noted that the patient had been diagnosed with a third degree burn (burns third degree/third degree burn). Medical records from the emergency room visit in 2009 revealed that the patient had a 2. 5cm by 4cm area of redness (erythema/redness) where a blister was open and the skin was gone (burns second degree/blisters, with epidermal loss due to burn (second degree) of neck). The diagnosis was an acute minor second degree burn. There was no evidence of surrounding cellulitis and no edema. The patient's sensation was intact. Treatment included burn/wound care, bactroban ointment, iodoform gauze dressing and a tetanus shot. She was discharged to home the same day, in stable condition. Medical records from the emergency room visit about 11 days later revealed that the patient was found to have pus on the gauze of her burn dressing (wound secretion/wound secretion). The patient's daughter stated she had a third degree burn on the back of her neck due to a thermal pack. A third degree burn on the back of her neck was noted during physical examination, but there was no evidence of cellulitis. The wound was cleaned with saline and dressed. A gram stain indicated moderate yeast (not candida albicans). A prescription was given for biaxin 500mg bid for 10 days and bactroban cream (30g) bid for 10 days. Two sutures which had been on her left ear were removed and a dressing was applied. The patient described her pain as constant sharp/stabbing pain (pian/pain) and her pain level was 3 out of 10. She was diagnosed with impetigo (impetigo/impetigo). The patient was referred to a plastic surgeon for further treatment. Her daughter was educated on use of aseptic techniques and pain control measures. The patient was discharged home with care notes on impetigo. The events were not recovered.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1066015-2009-00003
MDR Report Key1399111
Report Source04
Date Received2009-06-04
Date of Report2009-04-10
Date of Event2009-04-10
Date Mfgr Received2009-05-11
Date Added to Maude2009-06-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location0
Manufacturer ContactJILL ROBINSON
Manufacturer StreetP.O. BOX 7667
Manufacturer CityPHILADELPHIA PA 191017667
Manufacturer CountryUS
Manufacturer Postal191017667
Manufacturer Phone4848656841
Manufacturer G1WYETH CONSUMER HEALTHCARE
Manufacturer Street1231 WYANDOTTE DRIVE
Manufacturer CityALBANY GA 31705
Manufacturer CountryUS
Manufacturer Postal Code31705
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTHERMACARE HEATWRAPS, NECK, SHOULDER & WRIST (NOT APPLICABLE) WRAP 1APPLIC
Generic NameDISPOSABLE PACK, HOT
Product CodeOMW
Date Received2009-06-04
Lot Number8214U018S
Device Expiration Date2011-07-01
OperatorLAY USER/PATIENT
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerWYETH CONSUMER HEALTHCARE
Manufacturer AddressALBANY GA US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2009-06-04

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.