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| Device Problems
Insufficient Heating (1287); Product Quality Problem (1506)
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| Patient Problems
Pain (1994); Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)
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| Event Date 03/26/2015 |
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Event Type
Injury
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Event Description
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Third degree burns [burns third degree].Blisters, might be a 2nd degree burn/ i had 2nd degree burns [burns second degree].Burn/ burns from the wrap [thermal burn].Used more than one wrap on the day when she had burn and blisters, used for 10-12 hours, had to constantly warm them up [intentional device misuse].They started getting cold so fast that they had to constantly warm them up [product quality issue].Case description: this is a spontaneous report from a contactable consumer or other non hcp.A (b)(6) female patient started to receive thermacare heatwrap (thermacare heatwrap) from an unspecified date for an unspecified indication.The patient's medical history included a total abdominal hysterectomy (tah) on (b)(6) 2015.Concomitant medication included hydromorphone hydrochloride (dilaudid) at an unknown dose and frequency for pain following her tah.Past product history included thermacare heatwraps (thermacare heatwraps) on an unspecified date for an unspecified indication and reported she had slept with them.The patient reported after having a tah, she was given thermacare heatwraps.On (b)(6) 2015, the patient reported using the heatwrap for 10-12 hours with the nurse checking the skin under the wrap approximately every 2 hours.She mentioned the heatwraps would get cold so fast that they had to constantly warm them up.She stated the pain returned after a couple of hours so she asked for another heatwrap.The nurse brought her another heatwrap and the patient used it from approximately 6:15 am until her physician stopped in to see her incision site at 7:15 am.The patient reported her physician informed her she had a big burn, a couple small burns and 2 blisters 3cm x 3cm in size on her lower abdomen.The physician mentioned the area of the burns and blisters was kind of red and instructed to keep the area dry, covered and intact.The patient stated she did not know about the diagnosis but it might be a second degree burn and they have documented it in the hospital.She reported her incisions were recovered from the surgery but the burns had to be kept dry and intact.So, she had a bandage on them.She mentioned that there was some fluid in the blisters and in the hospital they drained the fluid but it came back again.The patient had no associated symptoms like pain, fever, swelling or rash.The patient assessed her skin tone as medium.She did not have any problems like diabetes, rheumatoid arthritis, heart disease, neuropathy and any skin allergies like skin rashes, sensitive skin or any other skin disorders.The patient mentioned she did not use any creams, rubs or gels under the wrap.She stated there were no defects on the wrap like cuts, tears, holes or leaks.The patient did not change or modify the wrap in any way.She mentioned she did not feel the wrap was getting too hot.The patient reported she did not put the heatwrap in the microwave and did not use it overnight while sleeping.She did not use the wrap directly against the skin and used it over the correct part of the body.The patient did not overlap the heatwrap and did not exercise while using the heatwrap.She did not apply any pressure over the wrap and did not wear more than 2 layers of clothing over the wrap.The patient did not sit or recline for a prolonged period of time.Action taken with the product was unknown.Therapeutic measures received included drainage of the blisters and bandages to keep the burn site covered, dry and intact.At the time of the report, clinical outcome of the event was unknown.Additional information received on 04may2015 from the patient's lawyer stating the patient has retained legal counsel.Additional information has been requested and will be provided as it becomes available.Follow up (07apr2015): new information received from a contactable consumer includes: medical history onset date of tah.Follow up (04may2015): new information received from a contactable consumer (lawyer) includes: patient has retained legal counsel as a result of the events.This case has been upgraded to a serious, reportable medical device report.Follow-up (28may2015): follow-up attempts completed.No further information expected.Follow-up (22jun2015): this is a spontaneous report from a contactable consumer received from united states food and drug administration (us fda).The regulatory authority report number is mw5042043.As of (b)(6) 2015, it was reported that this female patient (she was in the hospital for hysterectomy) given a thermacare heatwrap (thermacare heatwrap) and after an hour she had 2nd degree burns from the wrap on (b)(6) 2015.It was also reported that she was hospitalized for 2nd degree burns.Follow-up (01dec2015): this contactable attorney reported by way of consumer questionnaire.This female patient applied thermacare heatwrap (thermacare menstrual) during hospitalization on (b)(6) 2015 to her lower abdomen between navel and pubic area for abdominal pain and cramping after a hysterectomy procedure.The thermacare heatwrap was removed on the morning of(b)(6) 2015.The thermacare heatwrap was not reheated during use and applied directly on her skin.The thermacare heatwrap was applied by a nurse/medical care professional while the patient sedated and left the product while sleeping.Her skin was checked by medical personnel while using thermacare heatwrap.During hospitalization after surgery on (b)(6) 2015, she developed pain and severe burns and diagnosed with third degree burns.The patient had burns in the area of a surgical incision.On an unknown date, she was on wound care including debridement's and underwent skin grafting procedure and received unknown medical treatment for third degree burns.At the time of this report, she was under the care of a medical doctor.As of (b)(6) 2015, the clinical outcome of the event third degree burns was unknown.
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Event Description
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Case description: this is a spontaneous report from a contactable consumer or other non hcp.A (b)(6) caucasian female patient started to receive thermacare heatwrap (thermacare heatwrap) from an unspecified date for an unspecified indication.The patient's medical history included a total abdominal hysterectomy (tah) on (b)(6) 2015.Concomitant medication included hydromorphone hydrochloride (dilaudid) at an unknown dose and frequency for pain following her tah.Past product history included thermacare heatwraps (thermacare heatwraps) on an unspecified date for an unspecified indication and reported she had slept with them.The patient reported after having a tah, she was given thermacare heatwraps.On (b)(6) 2015, the patient reported using the heatwrap for 10-12 hours with the nurse checking the skin under the wrap approximately every 2 hours.She mentioned the heatwraps would get cold so fast that they had to constantly warm them up.She stated the pain returned after a couple of hours so she asked for another heatwrap.The nurse brought her another heatwrap and the patient used it from approximately 6:15 am until her physician stopped in to see her incision site at 7:15 am.The patient reported her physician informed her she had a big burn, a couple small burns and 2 blisters 3cm x 3cm in size on her lower abdomen.The physician mentioned the area of the burns and blisters was kind of red and instructed to keep the area dry, covered and intact.The patient stated she did not know about the diagnosis but it might be a second degree burn and they have documented it in the hospital.She reported her incisions were recovered from the surgery but the burns had to be kept dry and intact.So, she had a bandage on them.She mentioned that there was some fluid in the blisters and in the hospital they drained the fluid but it came back again.The patient had no associated symptoms like pain, fever, swelling or rash.The patient assessed her skin tone as medium.She did not have any problems like diabetes, rheumatoid arthritis, heart disease, neuropathy and any skin allergies like skin rashes, sensitive skin or any other skin disorders.The patient mentioned she did not use any creams, rubs or gels under the wrap.She stated there were no defects on the wrap like cuts, tears, holes or leaks.The patient did not change or modify the wrap in any way.She mentioned she did not feel the wrap was getting too hot.The patient reported she did not put the heatwrap in the microwave and did not use it overnight while sleeping.She did not use the wrap directly against the skin and used it over the correct part of the body.The patient did not overlap the heatwrap and did not exercise while using the heatwrap.She did not apply any pressure over the wrap and did not wear more than 2 layers of clothing over the wrap.The patient did not sit or recline for a prolonged period of time.Action taken with the product was unknown.Therapeutic measures received included drainage of the blisters and bandages to keep the burn site covered, dry and intact.At the time of the report, clinical outcome of the event was unknown.Additional information received on 04may2015 from the patient's lawyer stating the patient has retained legal counsel.Additional information has been requested and will be provided as it becomes available.Follow up (07apr2015): new information received from a contactable consumer includes: medical history onset date of tah.Follow up (04may2015): new information received from a contactable consumer (lawyer) includes: patient has retained legal counsel as a result of the events.This case has been upgraded to a serious, reportable medical device report.Follow-up (28may2015): follow-up attempts completed.No further information expected.Follow-up (22jun2015): this is a spontaneous report from a contactable consumer received from united states food and drug administration (us fda).The regulatory authority report number is mw5042043.As of 14apr2015, it was reported that this female patient (she was in the hospital for hysterectomy) given a thermacare heatwrap (thermacare heatwrap) and after an hour she had 2nd degree burns from the wrap on (b)(6) 2015.It was also reported that she was hospitalized for 2nd degree burns.Follow-up (01dec2015): this contactable attorney reported by way of consumer questionnaire.This female patient applied thermacare heatwrap (thermacare menstrual) during hospitalization on (b)(6) 2015 to her lower abdomen between navel and pubic area for abdominal pain and cramping after a hysterectomy procedure.The thermacare heatwrap was removed on the morning of (b)(6) 2015.The thermacare heatwrap was not reheated during use and applied directly on her skin.The thermacare heatwrap was applied by a nurse/medical care professional while the patient sedated and left the product while sleeping.Her skin was checked by medical personnel while using thermacare heatwrap.During hospitalization after surgery on (b)(6) 2015, she developed pain and severe burns and diagnosed with third degree burns.The patient had burns in the area of a surgical incision.On an unknown date, she was on wound care including debridement's and underwent skin grafting procedure and received unknown medical treatment for third degree burns.At the time of this report, she was under the care of a medical doctor.As of 01dec2015, the clinical outcome of the event third degree burns was unknown.Follow-up (09may2016): this contactable attorney reported by way of medical records.This female patient's social history was significant for cigarette smoking 1 to 10 per day, opioid dependence (treated with buprenorphine/naloxone (suboxone) low dose) and substance abuse (took psychiatric care to overcome addiction) on an unknown date.Her family history was significant for chronic obstructive pulmonary disease (mother), fibromyalgia (mother and unknown family member), osteoarthritis (father), lupus, hypertension, coronary artery disease and lung cancer (unknown family members) and acute myocardial infarction (mi) (due to which paternal grandfather died) on an unknown date.On (b)(6) 2015, she underwent carmellose (aquacel) dressing and covered it with a regular dressing for burn.On (b)(6) 2015, the patient's blister was back for which she was recommended to keep the incision covered, change dressing daily and watch for redness, fever or increased pain.On (b)(6) 2015, she presented to urgent care complaining of burning pain in the area of burn, where she was examined and dressing was applied.On (b)(6) 2015, the patient had a follow-up visit for abdominal burns.She was treated with ice packs to alleviate the pain and underwent excisional sharps debridement of abdominal wounds/burns.On (b)(6) 2015, she was admitted to the hospital for abdomen burn and underwent debridement and got discharged on the same day.On (b)(6) 2015, she underwent tangential excision of burn wounds totaling 1 percent total body surface area (tbsa).On (b)(6) 2015, she experienced pain at the burns location.It was reported that her burn was nicely healing at that point of time and was recommended daily dressings with carmellose.On (b)(6) 2015, it was reported that the patient underwent local debridement of the thermal burn.She was hospitalized on (b)(6) 2015 and got discharged on the same day for third-degree abdominal burn wounds.On an unknown date, she underwent burn wound excision followed by split thickness skin graft closure.
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