MAUDE Adverse Event Report: PROCTER & GAMBLE HEALTH CARE THERMACARE HEATWRAP; DISPOSABLE PACK, HOT

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Scar Tissue (2060); Skin Discoloration (2074); Swelling (2091); Urticaria (2278); Complaint, Ill-Defined (2331); Sleep Dysfunction (2517); Burn, Thermal (2530); Fluid Discharge (2686); Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)

Event Date 12/28/2002

Event Type  Injury  

Manufacturer Narrative

Company clinical evaluation comment: based on the information provided, the events burns second degree, burns third degree, hemorrhage, blisters, and wound oozing as described in this case are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other events thermal burn, urticarial, pain, insomnia, swelling, skin disorder, keloid scar, skin discoloration, drug administration error are assessed as associated with the device.This case meets initial 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events burns second degree, burns third degree, hemorrhage, blisters, and wound oozing as described in this case are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other events thermal burn, urticarial, pain, insomnia, swelling, skin disorder, keloid scar, skin discoloration, drug administration error are assessed as associated with the device.This case meets initial 10-day eu and 30-day fda reportability.

Event Description

Third degree burns [burns third degree].Second degree burn [burns second degree].Bleeding [haemorrhage].Blisters on back/ 4 blisters about the size of dimes/ one of the blister's had fluid in it [blister].Burns oozing [wound secretion].Burn back [thermal burn].Welts on back [urticaria].Pain/burning pain on her back [pain].Can not sleep [insomnia].Drug misadministration (contra condition: new diabetic) [drug administration error].Swelling [swelling) pink flesh was exposed [skin disorder].Dark marks [skin discolouration].Starting to keloid [keloid scar].Case description: this is a spontaneous report from a contactable nurse.A (b)(6) black female patient started to receive thermacare heatwrap (thermacare heatwrap), topical on (b)(6) 2002 at 1 application once only for back pain.Medical history included drug hypersensitivity to darvon, darvocet, and chloromicidin, food allergy to shellfish, iv iodine allergy, diabetes mellitus non-insulin-dependent, arthritis, and high blood pressure.Consumer is a newfound diabetic but used product for 6-7 months with no problem.Concomitant medication included labetalol (labetalol), hydrochlorothiazide (hydrochlorothiazide), and lisinopril (lisinopril).On (b)(6) 2002, the patient applied one heatwrap for 3 hours and experienced second degree burn, burn back, blisters on back, 4 blisters about the size of dimes, one of the blister's had fluid in it and welts on back.On an unspecified date, the patient with diabetes mellitus used thermacare heatwrap and experienced pain/burning pain on her back, bleeding, third degree burns, burns oozing, swelling, pink flesh was exposed, dark marks, cannot sleep, and starting to keloid.Action taken in response to the events for thermacare heatwrap was permanently withdrawn on (b)(6) 2002.Therapeutic measures were taken as a result of the events included silvadene cream topically to the burn area and vicodin.The outcome of burns second degree, thermal burn, blister, urticarial, insomnia, drug administration error, swelling, skin disorder, wound oozing, haemorrhage, and burns third degree were recovered.The outcome of pain, skin discolouration, and keloid scar were not recovered.Follow-up (august 04, 2015): new information from the same nurse reporting for herself included: reaction data (events: third degree burns and bleeding, and event description: burning pain on her back, 4 blisters about the size of dimes, one of the blister's had fluid in it).

• Brand Name: THERMACARE HEATWRAP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PROCTER & GAMBLE HEALTH CARE; albany GA
• Manufacturer (Section G): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• Manufacturer Contact: 219 east 42nd st. ; new york, NY 10017 ; 2127335544
• MDR Report Key: 5010116
• MDR Text Key: 23257482
• Report Number: 1066015-2015-00102
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Report Date: 12/30/2002

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LABETALOL
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 73