|
|
| Lot Number F50555B |
| Device Problem
Patient-Device Incompatibility (2682)
|
| Patient Problems
Erythema (1840); Itching Sensation (1943); Rash (2033); Red Eye(s) (2038); Swelling (2091); Electrolyte Imbalance (2196); Urticaria (2278); Fluid Discharge (2686)
|
| Event Date 07/18/2014 |
|
Event Type
Injury
|
|
Event Description
|
|
Broke out into hives all over the body [urticaria].Eyes were shut [eye swelling].Potassium level was low [blood potassium decreased].Case description: this is an initial spontaneous report by a contactable consumer.This (b)(6) female patient started using thermacare heatwrap (thermacare neck, shoulder and wrist) (lot number: f505558, expiration date: july 2014) at an unknown frequency for stiff neck and shoulder on (b)(6) 2014.The patient's medical history was none.Relevant concomitant medications included unspecified medications and it was unknown if they were ongoing at the time of event onset.On (b)(6) 2014, the patient reported immediately after the heatwrap released heat she "broke out into hives all over her body" and her "eyes were shut" so, she was sent to the emergency room on (b)(6) 2014 and then again on (b)(6) 2014.On (b)(6) 2014, she stopped using heatwrap in response to the above mentioned events.On (b)(6) 2014, after she stopped using heatwrap, she reported having unspecified blood work which revealed a low potassium level.Relevant lab data included unspecified blood work on (b)(6) 2014 revealing "potassium level was low." at the time of report she was not using heatwrap.Therapeutic measures taken for the reported events included unspecified antihistamines, unspecified intravenous medications, diphenhydramine, (benadryl) and five different unspecified medications.At the time of the report she had not recovered from the event "broke out into hives all over the body," and had recovered from the above mentioned event "eyes were shut" in (b)(6) 2014.At the time of the report the clinical outcome of the event "potassium level was low" was unknown.No follow-up attempts possible.No further information expected.Follow-up (04/17/2015): this contactable attorney reported by way of medical records.This female patient's medical history included seasonal allergy, fuch disease and allergic to sulfa drugs (hives) on an unknown date.On (b)(6) 2014, after she began using thermacare wrap, she had itching, redness on the neck, face, right upper abdomen and chest, swelling on face and she was diagnosed with allergic reaction hives.On (b)(6) 2014, physical examination of skin showed rash, red, vesicular, itchy with pustules, draining clear fluid to face, especially left side and left eye was very swollen, redness and swelling to the face and anterior neck, redness under the bilateral breasts and to the groin region and had oozing vesicles to her left temple, neck, left ear, under right breast and right groin.On (b)(6) 2014, her potassium levels were 3.2 mmol/l (3.5-5.3) and she was diagnosed with hypokalemia.She was treated with nystatin topical cream 100000 microgram twice daily, prednisone tablet 20 mg oral every morning, methylprednisolone sodium succinate 125 mg by intravenous (iv) route once for one dose, methylprednisolone (solumedrol) 125 mg iv, diphenhydramine (benadryl) 50 mg/ml one ml by iv route once for one dose and diphenhydramine (benadryl) 50 mg one tablet orally twice daily for hives and potassium chloride (k-dur) 20 extended release tablet 20 meq oral daily for hypokalemia.
|
| |
|
Event Description
|
|
Case description: this is an initial spontaneous report by a contactable consumer.This (b)(6) white female patient started using thermacare heatwrap (thermacare neck, shoulder & wrist)(lot number: f50555b, expiration date:jul2014) from (b)(6) 2014 for stiff neck and shoulder.The patient's medical history was none.Relevant concomitant medications included unspecified medications and it was unknown if they were ongoing at the time of event onset.On (b)(6) 2014, the patient reported immediately after the heatwrap released heat she "broke out into hives all over her body" and her "eyes were shut" so, she was sent to the emergency room on (b)(6) 2014 and then again on (b)(6) 2014.On (b)(6) 2014 she stopped using heatwrap in response to the above mentioned events.On (b)(6) 2014 after she stopped using heatwrap, she reported having unspecified blood work which revealed a low potassium level.Relevant lab data included unspecified blood work on (b)(6) 2014 revealing "potassium level was low".At the time of report she was not using heatwrap.Therapeutic measures taken for the reported events included unspecified antihistamines, unspecified intravenous medications, diphenhydramine, (benadryl) and five different unspecified medications.At the time of the report she had not recovered from the event "broke out into hives all over the body", and had recovered from the above mentioned event "eyes were shut" in (b)(6) 2014.At the time of the report the clinical outcome of the event "potassium level was low" was unknown.Additional information received from product quality complaint (pqc) group on (b)(6) 2015 provided quality assurance (qa) investigation results.The plant has reviewed this batch from a manufacturing and technical perspective.No quality issues were identified upon review of batch device history records, in process quality check results or inspection of retained samples.Retained samples met the product description.The product has exceeded the expiration date of jul2014.After a review of the batch thermal records, thermal results met the required specifications.Consumer alleges itching, and redness to the neck and face after applying the wrap.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.No follow-up attempts possible.No further information expected.Follow-up (17apr2015): this contactable attorney reported by way of medical records.This female patient's medical history included seasonal allergy, fuch disease and allergic to sulfa drugs (hives) on an unknown date.On (b)(6) 2014, after she began using thermacare wrap, she had itching, redness on the neck, face, right upper abdomen and chest, swelling on face and she was diagnosed with allergic reaction hives.On (b)(6) 2014, physical examination of skin showed rash, red, vesicular, itchy with pustules, draining clear fluid to face, especially left side and left eye was very swollen, redness and swelling to the face and anterior neck, redness under the bilateral breasts and to the groin region and had oozing vesicles to her left temple, neck, left ear, under right breast and right groin.On (b)(6) 2014, her potassium levels were 3.2 mmol/l (3.5-5.3) and she was diagnosed with hypokalemia.She was treated with nystatin topical cream 100000 microgram twice daily, prednisone tablet 20 mg oral every morning, methylprednisolone sodium succinate 125 mg by intravenous (iv) route once for one dose, methylprednisolone (solumedrol) 125 mg iv, diphenhydramine (benadryl) 50 mg/ml one ml by iv route once for one dose and diphenhydramine (benadryl) 50 mg one tablet orally twice daily for hives and potassium chloride (k-dur) 20 extended release tablet 20 meq oral daily for hypokalemia.Follow-up (19jun2015): new information received from product quality complaints (pqc) group included: quality assurance (qa) investigation results.No follow-up attempts possible.No further information expected.Follow-up (15jan2016): this contactable attorney reported by way of complaint.This female patient purchased thermacare heatwrap (thermacare neck, shoulder & wrist) in feb2014 and was placed on her neck for stiff neck and right shoulder on (b)(6) 2014.On (b)(6) 2014, she began to experience discomfort and discoloration including but not limited to appearance of hives and rash and removed thermacare heatwrap on same day.On (b)(6) 2014, her condition had intensified and dispersed throughout her body, leaving discoloration, hives and rashes on her legs, groin area and underneath her breasts and also swelling in her lips, left eye and face.On same day, she was diagnosed with severe allergic reaction and was prescribed with muscle relaxers and treated with intravenous (iv) diphenhydramine (benadryl) and methylprednisolone (solu-medrol).On (b)(6) 2014, her condition was worsened and discoloration, hives, rash and swelling had continued to spread throughout her body and she went to emergency room on the same day.As of (b)(6) 2016, the clinical outcome of the events severe allergic reaction, discomfort, discoloration, rash/rashes on legs/rash spread throughout her body, her condition had intensified/ her condition was worsened, swelling had continued to spread throughout her body, rash, red, vesicular, itchy with pustules, draining clear fluid to face, especially left side/ oozing vesicles to her left temple, neck, left ear, under right breast and right groin was unknown.Follow-up (01feb2016): this contactable attorney reported by way of summons and complaint.On or around (b)(6) 2014, this female patient had rashes on her scalp.Follow-up (17feb2016): this follow-up report is being submitted to amend previously reported information: suspect product lot number updated from f505558 to f50555b.Follow-up (21mar2016): this follow-up report is being submitted to amend previously reported information: relevant medical history of sulfonamide allergy updated to past drug event of sulfonamide with reaction of hives.
|
| |
|
Event Description
|
|
Case description: this is an initial spontaneous report by a contactable consumer.This (b)(6) white female patient started using thermacare heatwrap (thermacare neck, shoulder & wrist)(lot number: f50555b, expiration date:jul2014) from (b)(6) 2014 for stiff neck and shoulder.The patient's medical history was none.Relevant concomitant medications included unspecified medications and it was unknown if they were ongoing at the time of event onset.On (b)(6) 2014, the patient reported immediately after the heatwrap released heat she "broke out into hives all over her body" and her "eyes were shut" so, she was sent to the emergency room on (b)(6) 2014 and then again on (b)(6) 2014.On (b)(6) 2014 she stopped using heatwrap in response to the above mentioned events.On (b)(6) 2014 after she stopped using heatwrap, she reported having unspecified blood work which revealed a low potassium level.Relevant lab data included unspecified blood work on (b)(6) 2014 revealing "potassium level was low".At the time of report she was not using heatwrap.Therapeutic measures taken for the reported events included unspecified antihistamines, unspecified intravenous medications, diphenhydramine, (benadryl) and five different unspecified medications.At the time of the report she had not recovered from the event "broke out into hives all over the body", and had recovered from the above mentioned event "eyes were shut" in (b)(6) 2014.At the time of the report the clinical outcome of the event "potassium level was low" was unknown.Additional information received from product quality complaint (pqc) group on 19jun2015 provided quality assurance (qa) investigation results.The plant has reviewed this batch from a manufacturing and technical perspective.No quality issues were identified upon review of batch device history records, in process quality check results or inspection of retained samples.Retained samples met the product description.The product has exceeded the expiration date of jul2014.After a review of the batch thermal records, thermal results met the required specifications.Consumer alleges itching, and redness to the neck and face after applying the wrap.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.No follow-up attempts possible.No further information expected.Follow-up (17apr2015): this contactable attorney reported by way of medical records.This female patient's medical history included seasonal allergy, fuch disease and allergic to sulfa drugs (hives) on an unknown date.On (b)(6) 2014, after she began using thermacare wrap, she had itching, redness on the neck, face, right upper abdomen and chest, swelling on face and she was diagnosed with allergic reaction hives.On (b)(6) 2014, physical examination of skin showed rash, red, vesicular, itchy with pustules, draining clear fluid to face, especially left side and left eye was very swollen, redness and swelling to the face and anterior neck, redness under the bilateral breasts and to the groin region and had oozing vesicles to her left temple, neck, left ear, under right breast and right groin.On (b)(6) 2014, her potassium levels were 3.2 mmol/l (3.5-5.3) and she was diagnosed with hypokalemia.She was treated with nystatin topical cream 100000 microgram twice daily, prednisone tablet 20 mg oral every morning, methylprednisolone sodium succinate 125 mg by intravenous (iv) route once for one dose, methylprednisolone (solumedrol) 125 mg iv, diphenhydramine (benadryl) 50 mg/ml one ml by iv route once for one dose and diphenhydramine (benadryl) 50 mg one tablet orally twice daily for hives and potassium chloride (k-dur) 20 extended release tablet 20 meq oral daily for hypokalemia.Follow-up (19jun2015): new information received from product quality complaints (pqc) group included: quality assurance (qa) investigation results.No follow-up attempts possible.No further information expected.Follow-up (15jan2016): this contactable attorney reported by way of complaint.This female patient purchased thermacare heatwrap (thermacare neck, shoulder & wrist) in (b)(6) 2014 and was placed on her neck for stiff neck and right shoulder on (b)(6) 2014.On (b)(6) 2014, she began to experience discomfort and discoloration including but not limited to appearance of hives and rash and removed thermacare heatwrap on same day.On (b)(6) 2014, her condition had intensified and dispersed throughout her body, leaving discoloration, hives and rashes on her legs, groin area and underneath her breasts and also swelling in her lips, left eye and face.On same day, she was diagnosed with severe allergic reaction and was prescribed with muscle relaxers and treated with intravenous (iv) diphenhydramine (benadryl) and methylprednisolone (solu-medrol).On (b)(6) 2014, her condition was worsened and discoloration, hives, rash and swelling had continued to spread throughout her body and she went to emergency room on the same day.As of (b)(6) 2016, the clinical outcome of the events severe allergic reaction, discomfort, discoloration, rash/rashes on legs/rash spread throughout her body, her condition had intensified/ her condition was worsened, swelling had continued to spread throughout her body, rash, red, vesicular, itchy with pustules, draining clear fluid to face, especially left side/ oozing vesicles to her left temple, neck, left ear, under right breast and right groin was unknown.Follow-up (01feb2016): this contactable attorney reported by way of summons and complaint.On or around (b)(6) 2014, this female patient had rashes on her scalp.Follow-up (17feb2016): this follow-up report is being submitted to amend previously reported information: suspect product lot number updated from f505558 to f50555b.
|
| |
|
Manufacturer Narrative
|
|
Evaluation summary: the plant has reviewed this batch from a manufacturing and technical perspective.No quality issues were identified upon review of batch device history records, in process quality check results or inspection of retained samples.Retained samples met the product description.The product has exceeded the expiration date of jul2014.After a review of the batch thermal records, thermal results met the required specifications.Consumer alleges s an itching, and redness to the neck and face after applying the wrap.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.
|
| |
|
Event Description
|
|
Case description: this is an initial spontaneous report by a contactable consumer.This (b)(6)-year-old white female patient started using thermacare heatwrap (thermacare neck, shoulder & wrist) (lot number: f50555b, expiration date:jul2014) from (b)(6) 2014 for stiff neck and shoulder.The patient's medical history was none.Relevant concomitant medications included unspecified medications and it was unknown if they were ongoing at the time of event onset.On (b)(6) 2014, the patient reported immediately after the heatwrap released heat she "broke out into hives all over her body" and her "eyes were shut" so, she was sent to the emergency room on (b)(6) 2014 and then again on (b)(6) 2014.On (b)(6) 2014 she stopped using heatwrap in response to the above mentioned events.On (b)(6) 2014 after she stopped using heatwrap, she reported having unspecified blood work which revealed a low potassium level.Relevant lab data included unspecified blood work on (b)(6) 2014 revealing "potassium level was low".At the time of report she was not using heatwrap.Therapeutic measures taken for the reported events included unspecified antihistamines, unspecified intravenous medications, diphenhydramine, (benadryl) and five different unspecified medications.At the time of the report she had not recovered from the event "broke out into hives all over the body", and had recovered from the above mentioned event "eyes were shut" in (b)(6) 2014.At the time of the report the clinical outcome of the event "potassium level was low" was unknown.Additional information received from product quality complaint (pqc) group on 19jun2015 provided quality assurance (qa) investigation results.The plant has reviewed this batch from a manufacturing and technical perspective.No quality issues were identified upon review of batch device history records, in process quality check results or inspection of retained samples.Retained samples met the product description.The product has exceeded the expiration date of jul2014.After a review of the batch thermal records, thermal results met the required specifications.Consumer alleges itching, and redness to the neck and face after applying the wrap.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.No follow-up attempts possible.No further information expected.Follow-up (17apr2015): this contactable attorney reported by way of medical records.This female patient's medical history included seasonal allergy, fuch disease and allergic to sulfa drugs (hives) on an unknown date.On (b)(6) 2014, after she began using thermacare wrap, she had itching, redness on the neck, face, right upper abdomen and chest, swelling on face and she was diagnosed with allergic reaction hives.On (b)(6) 2014, physical examination of skin showed rash, red, vesicular, itchy with pustules, draining clear fluid to face, especially left side and left eye was very swollen, redness and swelling to the face and anterior neck, redness under the bilateral breasts and to the groin region and had oozing vesicles to her left temple, neck, left ear, under right breast and right groin.On (b)(6) 2014, her potassium levels were 3.2 mmol/i (3.5-5.3) and she was diagnosed with hypokalemia.She was treated with nystatin topical cream 100000 microgram twice daily, prednisone tablet 20 mg oral every morning, methylprednisolone sodium succinate 125 mg by intravenous (iv) route once for one dose, methylprednisolone (solumedrol) 125 mg iv, diphenhydramine (benadryl) 50 mg/ml one ml by iv route once for one dose and diphenhydramine (benadryl) 50 mg one tablet orally twice daily for hives and potassium chloride (k-dur) 20 extended release tablet 20 meq oral daily for hypokalemia.Follow-up (19jun2015): new information received from product quality complaints (pqc) group included: quality assurance (qa) investigation results.No follow-up attempts possible.No further information expected.
|
| |
|
Event Description
|
|
Broke out into hives all over the body [urticaria], severe allergic reaction [hypersensitivity], eyes were shut [eye swelling], potassium level was low [blood potassium decreased], discomfort [discomfort], discoloration [skin discolouration], rash/rashes on legs/rash spread throughout her body [rash], her condition had intensified/ her condition was worsened [condition aggravated], swelling had continued to spread throughout her body [swelling], rash, red, vesicular, itchy with pustules, draining clear fluid to face, especially left side/ oozing vesicles to her left temple, neck, left ear, under right breast and right groin [rash vesicular], rash, red, vesicular, itchy with pustules, draining clear fluid to face, especially left side/ oozing vesicles to her left temple, neck, left ear, under right breast and right groin [rash pustular], rash, red, vesicular, itchy with pustules, draining clear fluid to face, especially left side/ oozing vesicles to her left temple, neck, left ear, under right breast and right groin [wound secretion].Case description: this is an initial spontaneous report by a contactable consumer.This (b)(6)-year-old white female patient started using thermacare heatwrap (thermacare neck, shoulder & wrist)(lot number: f50555b, expiration date:jul2014) from (b)(6) 2014 for stiff neck and shoulder.The patient's medical history was none.Relevant concomitant medications included unspecified medications and it was unknown if they were ongoing at the time of event onset.On (b)(6) 2014, the patient reported immediately after the heatwrap released heat she "broke out into hives all over her body" and her "eyes were shut" so, she was sent to the emergency room on (b)(6) 2014 and then again on (b)(6) 2014.On (b)(6) 2014 she stopped using heatwrap in response to the above mentioned events.On (b)(6) 2014 after she stopped using heatwrap, she reported having unspecified blood work which revealed a low potassium level.Relevant lab data included unspecified blood work on 21jul2014 revealing "potassium level was low".At the time of report she was not using heatwrap.Therapeutic measures taken for the reported events included unspecified antihistamines, unspecified intravenous medications, diphenhydramine, (benadryl) and five different unspecified medications.At the time of the report she had not recovered from the event "broke out into hives all over the body", and had recovered from the above mentioned event "eyes were shut" in (b)(6) 2014.At the time of the report the clinical outcome of the event "potassium level was low" was unknown.Additional information received from product quality complaint (pqc) group on 19jun2015 provided quality assurance (qa) investigation results.The plant has reviewed this batch from a manufacturing and technical perspective.No quality issues were identified upon review of batch device history records, in process quality check results or inspection of retained samples.Retained samples met the product description.The product has exceeded the expiration date of jul2014.After a review of the batch thermal records, thermal results met the required specifications.Consumer alleges itching, and redness to the neck and face after applying the wrap.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.No follow-up attempts possible.No further information expected.Follow-up (17apr2015): this contactable attorney reported by way of medical records.This female patient's medical history included seasonal allergy, fuch disease and allergic to sulfa drugs (hives) on an unknown date.On (b)(6) 2014, after she began using thermacare wrap, she had itching, redness on the neck, face, right upper abdomen and chest, swelling on face and she was diagnosed with allergic reaction hives.On (b)(6) 2014, physical examination of skin showed rash, red, vesicular, itchy with pustules, draining clear fluid to face, especially left side and left eye was very swollen, redness and swelling to the face and anterior neck, redness under the bilateral breasts and to the groin region and had oozing vesicles to her left temple, neck, left ear, under right breast and right groin.On (b)(6) 2014, her potassium levels were 3.2 mmol/l (3.5-5.3) and she was diagnosed with hypokalemia.She was treated with nystatin topical cream 100000 microgram twice daily, prednisone tablet 20 mg oral every morning, methylprednisolone sodium succinate 125 mg by intravenous (iv) route once for one dose, methylprednisolone (solumedrol) 125 mg iv, diphenhydramine (benadryl) 50 mg/ml one ml by iv route once for one dose and diphenhydramine (benadryl) 50 mg one tablet orally twice daily for hives and potassium chloride (k-dur) 20 extended release tablet 20 meq oral daily for hypokalemia.Follow-up (19jun2015): new information received from product quality complaints (pqc) group included: quality assurance (qa) investigation results.No follow-up attempts possible.No further information expected.Follow-up (15jan2016): this contactable attorney reported by way of complaint.This female patient purchased thermacare heatwrap (thermacare neck, shoulder & wrist) in (b)(6) 2014 and was placed on her neck for stiff neck and right shoulder on (b)(6) 2014.On (b)(6) 2014, she began to experience discomfort and discoloration including but not limited to appearance of hives and rash and removed thermacare heatwrap on same day.On (b)(6) 2014, her condition had intensified and dispersed throughout her body, leaving discoloration, hives and rashes on her legs, groin area and underneath her breasts and also swelling in her lips, left eye and face.On same day, she was diagnosed with severe allergic reaction and was prescribed with muscle relaxers and treated with intravenous (iv) diphenhydramine (benadryl) and methylprednisolone (solu-medrol).On (b)(6) 2014, her condition was worsened and discoloration, hives, rash and swelling had continued to spread throughout her body and she went to emergency room on the same day.As of (b)(6) 2016, the clinical outcome of the events severe allergic reaction, discomfort, discoloration, rash/rashes on legs/rash spread throughout her body, her condition had intensified/ her condition was worsened, swelling had continued to spread throughout her body, rash, red, vesicular, itchy with pustules, draining clear fluid to face, especially left side/ oozing vesicles to her left temple, neck, left ear, under right breast and right groin was unknown.
|
| |
|
Event Description
|
|
Broke out into hives all over the body [urticaria], severe allergic reaction [hypersensitivity], eyes were shut [eye swelling], potassium level was low [blood potassium decreased], discomfort [discomfort], discoloration [skin discolouration], rash/rashes on legs/rash spread throughout her body/ rashes on her scalp [rash], her condition had intensified/ her condition was worsened [condition aggravated], swelling had continued to spread throughout her body [swelling], rash, red, vesicular, itchy with pustules, draining clear fluid to face, especially left side/ oozing vesicles to her left temple, neck, left ear, under right breast and right groin [rash vesicular], rash, red, vesicular, itchy with pustules, draining clear fluid to face, especially left side/ oozing vesicles to her left temple, neck, left ear, under right breast and right groin [rash pustular], rash, red, vesicular, itchy with pustules, draining clear fluid to face, especially left side/ oozing vesicles to her left temple, neck, left ear, under right breast and right groin [wound secretion].Case description: this is an initial spontaneous report by a contactable consumer.This (b)(6)-year-old white female patient started using thermacare heatwrap (thermacare neck, shoulder & wrist)(lot number: f50555b, expiration date:jul2014) from (b)(6) 2014 for stiff neck and shoulder.The patient's medical history was none.Relevant concomitant medications included unspecified medications and it was unknown if they were ongoing at the time of event onset.On (b)(6) 2014, the patient reported immediately after the heatwrap released heat she "broke out into hives all over her body" and her "eyes were shut" so, she was sent to the emergency room on (b)(6) 2014 and then again on (b)(6) 2014.On (b)(6) 2014 she stopped using heatwrap in response to the above mentioned events.On (b)(6) 2014 after she stopped using heatwrap, she reported having unspecified blood work which revealed a low potassium level.Relevant lab data included unspecified blood work on (b)(6) 2014 revealing "potassium level was low".At the time of report she was not using heatwrap.Therapeutic measures taken for the reported events included unspecified antihistamines, unspecified intravenous medications, diphenhydramine, (benadryl) and five different unspecified medications.At the time of the report she had not recovered from the event "broke out into hives all over the body", and had recovered from the above mentioned event "eyes were shut" in (b)(6) 2014.At the time of the report the clinical outcome of the event "potassium level was low" was unknown.Additional information received from product quality complaint (pqc) group on 19jun2015 provided quality assurance (qa) investigation results.The plant has reviewed this batch from a manufacturing and technical perspective.No quality issues were identified upon review of batch device history records, in process quality check results or inspection of retained samples.Retained samples met the product description.The product has exceeded the expiration date of jul2014.After a review of the batch thermal records, thermal results met the required specifications.Consumer alleges itching, and redness to the neck and face after applying the wrap.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.No follow-up attempts possible.No further information expected.Follow-up (17apr2015): this contactable attorney reported by way of medical records.This female patient's medical history included seasonal allergy, fuch disease and allergic to sulfa drugs (hives) on an unknown date.On (b)(6) 2014, after she began using thermacare wrap, she had itching, redness on the neck, face, right upper abdomen and chest, swelling on face and she was diagnosed with allergic reaction hives.On (b)(6) 2014, physical examination of skin showed rash, red, vesicular, itchy with pustules, draining clear fluid to face, especially left side and left eye was very swollen, redness and swelling to the face and anterior neck, redness under the bilateral breasts and to the groin region and had oozing vesicles to her left temple, neck, left ear, under right breast and right groin.On (b)(6) 2014, her potassium levels were 3.2 mmol/l (3.5-5.3) and she was diagnosed with hypokalemia.She was treated with nystatin topical cream 100000 microgram twice daily, prednisone tablet 20 mg oral every morning, methylprednisolone sodium succinate 125 mg by intravenous (iv) route once for one dose, methylprednisolone (solumedrol) 125 mg iv, diphenhydramine (benadryl) 50 mg/ml one ml by iv route once for one dose and diphenhydramine (benadryl) 50 mg one tablet orally twice daily for hives and potassium chloride (k-dur) 20 extended release tablet 20 meq oral daily for hypokalemia.Follow-up (19jun2015): new information received from product quality complaints (pqc) group included: quality assurance (qa) investigation results.No follow-up attempts possible.No further information expected.Follow-up (15jan2016): this contactable attorney reported by way of complaint.This female patient purchased thermacare heatwrap (thermacare neck, shoulder & wrist) in (b)(6) 2014 and was placed on her neck for stiff neck and right shoulder on (b)(6) 2014.On (b)(6) 2014, she began to experience discomfort and discoloration including but not limited to appearance of hives and rash and removed thermacare heatwrap on same day.On (b)(6) 2014, her condition had intensified and dispersed throughout her body, leaving discoloration, hives and rashes on her legs, groin area and underneath her breasts and also swelling in her lips, left eye and face.On same day, she was diagnosed with severe allergic reaction and was prescribed with muscle relaxers and treated with intravenous (iv) diphenhydramine (benadryl) and methylprednisolone (solu-medrol).On (b)(6) 2014, her condition was worsened and discoloration, hives, rash and swelling had continued to spread throughout her body and she went to emergency room on the same day.As of (b)(6) 2016, the clinical outcome of the events severe allergic reaction, discomfort, discoloration, rash/rashes on legs/rash spread throughout her body, her condition had intensified/ her condition was worsened, swelling had continued to spread throughout her body, rash, red, vesicular, itchy with pustules, draining clear fluid to face, especially left side/ oozing vesicles to her left temple, neck, left ear, under right breast and right groin was unknown.Follow-up (01feb2016): this contactable attorney reported by way of summons and complaint.On or around (b)(6) 2014, this female patient had rashes on her scalp.
|
| |
|
Search Alerts/Recalls
|
|
|
