THERMACARE HEATWRAPS, BACK & HIP, SIZE UNK (NOT APPLICABLE) WRAP 1 APPLIC

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 2009-06-30 for THERMACARE HEATWRAPS, BACK & HIP, SIZE UNK (NOT APPLICABLE) WRAP 1 APPLIC manufactured by Wyeth Consumer Healthcare.

Event Text Entries

[1102363] Burn leg, burn hole in leg/second degree burn [burns second degree]. Cellulitis [cellulitis]. Chemical burn [caustic injury]. Burned a hole in leg (skin) [skin injury]. Blisters leg [blister]. Slight scar [scar]. Pain leg [pain in extremity]. Scab [scab]. Can't sleep [insomnia]. Upset [emotional distress]. Redness [erythema]. Achilles tendon tender [tendon pain]. Wound culture positive for staphylococcus aureus [staphylococcal infection]. Abscess formation [abscess]. Skin swollen [skin swelling]. Wound drainage [wound drainage]. Necrotic skin [skin necrosis]. Some of the contents came out of the heat discs [product quality issue]. Used a back wrap on his leg [device misuse]. Case description: a consumer reported that they, a male age unspecified, used thermacare pain relieving heatwraps, back, size unk 1 application applied to his back, unspecified frequency for 1 day in late 2006 and the wrap must have broken open and some of the contents of the heat discs came out and dripped onto the back of his leg. The area burned and blistered and he thought it could be infected. The consumer reported that he was applying vaseline to the area and it was starting to scab; he was in a lot of pain. The case outcome was not recovered/not resolved. Past medical history included: allergy - unk, medical history - "good health". No further info was provided. Eight days later, drug and poison info ctr f/u phone call: the consumer reported that he was not doing well and he was going to the emergency dept now. He reported that he cannot sleep and he cannot work. No further info was provided. The next day, received consumer's f/u phone call: the consumer reported that one of the gel capsules of the thermacare leaked out onto one of his legs and he was burnt. He reported that he went to the hosp two days prior and he had an infection and a chemical burn; he was experiencing excruciating pain and he was upset by the experience. He mentioned that he was out of work for two weeks. No further info was provided. Three days later, received consumer's f/u phone call: "the consumer reported that he had a burn on his from the thermacare wrap; he had an infection now and had not treated the infection with antibiotics. " no further info was provided. The same day received consumer's f/u phone call: the consumer reported that he was healing. No further info was provided. Five days later, received consumer's f/u phone call: the consumer reported that he spent a week in the hosp because of his experience with thermacare and while there he was getting his leg all cut open. The consumer mentioned that he missed two to three weeks of work. No further info was provided. On 11-dec-2006 review of data base on 11-dec-2006 revealed consumer's initial call. Consumer hung up when asked for additional info for health and safety: the consumer reported that he used thermacare back wrap on his leg and it burned a hole in his leg a week ago. He reported that he thought some of the gel came out of the product. The consumer discontinued use of the product. No further info was provided. On 08-apr-2008 received attorney's f/u letter: an attorney reported that the consumer sustained injuries as a result of a defective thermacare heatwrap product and suffered a burn injury which became infected and ultimately required surgery. No further info was provided. On 02-jun-2009 received attorney's f/u letter and pt's health care questionaire: info from an attorney and a questionaire revealed that the pt had second degree burns, cellulitis and still had a slight scar. Pt demographic info provided showed the pt was a male. It was reported that the pt applied the wrap on approximately the day prior to original date, when he went to bed, and removed it when he woke up the following morning. The pt wore the wrap for approximately 8 hrs. The pt slept with the wrap on and was lying on top of the wrap during the night. When he awoke, he noticed the blister. Due to his diabetes, the pt discussed the use of the heatwrap with his physician and the pt was instructed to wear something between the wrap and his skin. The pt did not check the skin under the product because he was sleeping. Additionally, it was reported that the pt had used the heatwrap on several occasions in the past. The questionnaire noted that the pt's overall skin condition was normal, his skin tone was very light/fair and that his skin burns moderately. It also noted that the pt denied having sensitive skin and denied perspiring while using the product. On 22-jun-2009 received medical records from emergency room and hosp admission: on eight days after the original date, the pt was seen in the emergency room (er) due to a chemical burn on his right lower leg. Upon presentation to the er, the pt's skin was noted to be red, swollen, painful, and draining. The pt reported that he noticed drainage several days prior to visiting the er. Since then, he had cleaned the wound daily with peroxide and treated it with bacitracin. Physical exam revealed a 2 cm area with eschar and circumferential erythema. Distal neurovascular was intact with no calf swelling. The pt was alert and oriented times three. Capillary refill was less than or equal to two seconds. The pt denied any fever, shaking or chills. He had no myalgia or arthralgia. The pt reported his pain was 10 out of 10. His vital signs were within normal limits. Treatment included intravenous levaquin (levofloxacin) 500 mg and normal saline. Forceps and scissors were used to sharply debride the eschar from the wound. The pt tolerated the procedure well. Culture and sensitivities were taken. He was diagnosed with cellulitis secondary to a chemical burn. The pt was sent home with percocet (oxycodone) for pain and levaquin 500 mg. The levaquin prescription was later changed to clindamycin 300 mg due to financial issues. The pt was instructed to f/u with his primary care physician in one to two days. Three days later, the pt was admitted to the hosp due to a burn of his lower leg with cellulitis and abscess formation. Upon admission, the pt complained of severe pain extending to his lower legs, redness and tenderness. The pt also noted increased redness and pain over the past 5 to 7 days and that his achilles tendon was tender. Upon exam, the pt was noted to have a 4 cm fluctuant mass covered by eschar with surrounding erythema, necrotic skin and cellulitis extending down the posterior portion of his leg. The pt reported his pain was a 5 or 6 out of 10. The pt was started on intravenous cefazolin 1 gram every 8 hrs, and bactroban/normal saline wet to dry dressings twice a day. An excisional debridement was scheduled. Upon admission, lab work showed the pt's white cell count was 6100, his hematocrit was 42% and his hemoglobin was 14. 5. His blood glucose was 458 mg/dl, hemoglobin a1c was 11. 7 and his urinalysis showed greater than 1000 mg of glucose. The records indicated that the pt had not been checking his blood sugars and had not been coming to the office for f/u. The pt was started on lantus (insulin glargine) and humalog (insulin lispro) to get his blood sugar under control. Four days later, his fasting blood sugar was 191 and the next day, it was well controlled at 106. The same day, the pt had an excisional debridement. The abscess was incised and a large amount of pus was drained. A good granulation base was noted during the procedure. The wound was copiously irrigated, was packed with gauze and then covered with a sterile dry dressing. Cultures and sensitivities were taken which showed moderate growth of staphylococcus aureus. The pt tolerated the procedure well and was sent to his room in stable condition. The pt showed improvement over the course of the hosp stay and was discharged to home the next day. His wound looked better at that time. Discharge medication included bactrim ds (sulfamethoxazole, trimethoprim) twice a day, lipitor (atorvastatin) 40 mg daily, glyburide (glibenclamide) 2. 5 mg daily if fasting blood sugar is above 120, lisinopril 5 mg daily, atenolol 25 mg daily, metformin 1 gram daily and percocet (oxycodone) one every four hrs as needed for pain. He was to apply warm compresses three times a day, followed with a dry dressing. The pt was instructed to f/u with his physician in 1 to 2 weeks. Five days later, the pt was seen for a f/u visit. The pt reported that he felt better and had no complaints. Upon exam, the wound was clean and showed good granulation. In early 2007, the pt was seen for a f/u visit and reported that he was doing fairly well and had gone back to work. On examination, the wound was noted to be small with minor erythema. He was continued on clindamycin. Six days later, the pt was seen for a f/u visit and the pt still had some complaints of pain. Upon exam, the wound was noted to be "almost healed" with only a small area still open. F/u visit the following month, noted that the wound was healed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1066015-2009-00005
MDR Report Key1409297
Report Source05
Date Received2009-06-30
Date of Report2006-12-07
Date of Event2006-12-02
Date Mfgr Received2009-06-02
Date Added to Maude2009-07-17
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 StreetPO BOX 7667
Manufacturer CityPHILADELPHIA PA 191017667
Manufacturer CountryUS
Manufacturer Postal191017667
Manufacturer Phone4848656841
Manufacturer G1WYETH CONSUMER HEALTHCARE
Manufacturer Street1231 WYANDOTTE DR
Manufacturer CityALBANY GA 31705
Manufacturer CountryUS
Manufacturer Postal Code31705
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTHERMACARE HEATWRAPS, BACK & HIP, SIZE UNK (NOT APPLICABLE) WRAP 1 APPLIC
Generic NameDISPOSABLE PACK, HOT
Product CodeOMW
Date Received2009-06-30
OperatorLAY USER/PATIENT
Device AvailabilityN
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 2009-06-30

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