THERMACARE HEATWRAPS, LOWER BACK & HIP (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 05 report with the FDA on 2009-06-04 for THERMACARE HEATWRAPS, LOWER BACK & HIP (NOT APPLICABLE) WRAP 1APPLIC manufactured by Wyeth Consumer Healthcare.

Event Text Entries

[19532299] Third degree burn/large burn to the back and left hip area [burns third degree]. Blister/large blister to the back and left hip area [blister]. Oozing/discharge [wound secretion]. Burned the top of her hand [thermal burn]. The wrap was so hot [device malfunction]. Pain [pain]. Pus [purulent discharge]. Large red [erythema]. Large red cellulosia [unevaluable event]. Case description: information was received from a healthcare professional/patient. The patient is a female who used a thermacare lower back and hip heatwrap (lot number d82002b and expiration date march 2012) transdermally for muscle pain in 2009. The patient experienced a third degree burn (burns third degree/third degree burns), blister (blister/blister) and oozing (wound secretion/wound oozing) the next day. On original date at 11:00 pm, the patient applied the product and fell asleep with the wrap on. The wrap fell off during the night, however, the patient cannot determined the exact time. She believes it was between 3:00 am and 4:00 am. It was reported that the blister is two inches wide and located above her left buttock. The blister popped at 6:00 am and was oozing. The patient, a nurse, stated that this is a third degree burn. She believes that burn will result in long-term scarring and will require medical attention. The patient denied using any topical medications while using the heat wrap. Thirteen days later, information indicated that the patient wore the product on her skin for 3 hours while awake, with underwear over it as pictured on the box. The patient checked the area while wearing the wrap and did not feel any burning. The patient experienced a large burn/blister to her back and left hip area that stopped oozing the day before. The patient reported that the wrap was so hot (device malfunction/device malfunction) upon removal that she burned the top of her hand (thermal burn/burn). She reported being unable to wear pants due to the blistering and being concerned about future scarring. Additionally, it was noted that the patient was treated by a physician for pain (pain/pain) with an unspecified pain medication and was given silvadene cream. The patient had not recovered. Additional information revealed that the patient went to urgent care for left hip pain, flu and a left buttocks burn with discharge. The patient reported that the burn was a 2 inch by 2 inch large red (erythema/skin red) cellulosia (unevaluable event/unevaluable event) and that it was a second degree burn (previously reported as a third degree burn). She also reported that there was a blistered area with pus (purulent discharge/purulent discharge) on her left buttocks. Additionally, the patient reported that the burn she received while removing the wrap was on her right hand and was 1 inch long. She alternated between calling this a first or second degree burn. The patient reiterated her concern that the burn on her had would scar in the future. The patient denied using any topical medication at the time of the events. Additional treatment included bedrest. Medical history included gastroesophageal reflux disease (gerd), presumed ocular histoplasmosis syndrome (pohs), left hip pain, flu and cancer. Concomitant medications included femara, prilosec and zantac. Not other information was provided. Third degree burns. Blister. Wound oozing. Burn. Device malfunction. Pain. Purulent discharge. Skin red. Unevaluable event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1066015-2009-00004
MDR Report Key1399110
Report Source05
Date Received2009-06-04
Date of Report2009-05-07
Date of Event2009-05-07
Date Mfgr Received2009-05-07
Date Added to Maude2009-06-30
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, LOWER BACK & HIP (NOT APPLICABLE) WRAP 1APPLIC
Generic NameDISPOSABLE PACK, HOT
Product CodeOMW
Date Received2009-06-04
Lot NumberD82002B
Device Expiration Date2012-03-01
OperatorHEALTH PROFESSIONAL
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

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