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

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-07-17 for THERMACARE ARTHRITIS HEATWRAPS, NECK, SHOULDER & WRIST (NOT APPLICABLE) WRAP 1AP manufactured by Wyeth Consumer Healthcare.

Event Text Entries

[1105378] Third degree burn [burn third degree], 2nd degree burn [burn second degree], keloid scar [keloid scar], "water blisters" [blister], slightly red [erythema], felt hot on back of neck [feeling hot]. Case description: additional info was received from a physician assistant that updated event details, medical history, concomitant medication and medically confirmed the case. Info was received from a relative regarding a female consumer who used a thermacare arthritis neck, shoulder and wrist heatwrap (lot# 7353u018s, expiration date nov. 2010) for neck cramps on an unspecified date in early 2009. It was reported that the pt wore the wrap directly on her skin and experienced water blisters (blisters/blisters) along the back of her neck and top of her shoulders, a severe burn, scarring, a slightly red neck (erythema/redness) and that it felt hot on the back of her neck (feeling hot/feeling hot). On an unspecified date in the same month, the pt wore the wrap for less than three hours when she felt hot on the back of her neck and removed the wrap. The reporter indicated that the pt wore the wrap after taking a shower, that no topicals were applied prior to use, and that the wrap was worn directly against the skin. The pt experienced "water blisters" along the back of her neck and top of her shoulders. The affected area was the entire width of the heat wrap and the blisters were the size of silver dollars. The pt was taken to a health care provider, treated with a burn cream, covered with non-stick bandages, and told that it was a "severe burn". It was reported that the water blisters were healing and that her neck was still slightly red. The reporter indicated that scarring "has/will" occur. The pt had used the product before with no incidents. At the time of the report, the events had not resolved. Additional info revealed that the pt experienced a second degree (burns second degree/second degree burns) and third degree burn (burns third degree/third degree burns) that required intervention. Additionally, the pt developed a keloid scar (keloid scar/keloid scar). The burn was reported to be 10cm by 4cm on the pt's upper back at the base of her neck. Surgical intervention involved tissue debridement every two to three days in the hospital (dates unspecified). Treatment also included wet to dry dressings and silvadene. At the time of the report, the events were considered resolved except for the scar that remained. No other info provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1066015-2009-00006
MDR Report Key1417785
Report Source05
Date Received2009-07-17
Date of Report2009-04-27
Date of Event2009-01-01
Date Mfgr Received2009-07-07
Date Added to Maude2009-07-27
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 ARTHRITIS HEATWRAPS, NECK, SHOULDER & WRIST (NOT APPLICABLE) WRAP 1AP
Generic NameDISPOSABLE PACK, HOT
Product CodeOMW
Date Received2009-07-17
Lot Number7353U018S
Device Expiration Date2010-11-01
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. Hospitalization; 2. Required No Informationntervention 2009-07-17

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