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| Lot Number N73395 |
| Device Problems
Use of Device Problem (1670); Suction Problem (2170); Material Twisted/Bent (2981)
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| Patient Problems
Discomfort (2330); Sweating (2444); Burn, Thermal (2530)
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Event Type
Injury
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Event Description
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Event verbatim [preferred term] burn spots on the back the size of a fifty cent coin similar in size to the "iron cells" [thermal burn] , open and red exuding wounds [wound] , from saturday midday to sunday morning with instructions to change the wrap every 8 hours (approximately 12 hours) [intentional device use issue] , new material is uncomfortable [discomfort] , sweating [hyperhidrosis] , material is not as good as before, the belt was twisting, the material no longer had a correct suction while sweating [device material issue].Case narrative:this is a spontaneous report from a contactable other health professional communicated to a company representative.A (b)(6) year-old female patient of an unspecified ethnicity started to use thermacare heatwrap (thermacare lower back & hip) (device lot number: n73395, expiration date jul2019) from an unspecified date for an unspecified indication.The patient's medical history included cat allergy, house dust allergy, hay fever, heart disease from an unspecified date and ongoing and heart attack in (b)(6) 2015.Concomitant medications included bisoprolol, ass, atorvastatin, ramipril and jodid.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.The patient reported she used the heatwrap from saturday midday to sunday morning despite instructions to change the wrap every 8 hours (used heatwrap approximately 12 hours) and experienced burn spots on the back the size of a fifty cent coin similar in size to the "iron cells" with open and red exuding wounds on an unspecified date.The patient had administered the product for years and was of the opinion that the material was not as good as before.She further stated that the belt was twisting, the material no longer had a correct suction while sweating etc.The patient reported the new material causes heat accumulation (meaning the material does not absorb the water), is uncomfortable and not skin-friendly.She stated in the past the material felt comfortable and did absorb the sweat.Action taken in response to the events for thermacare heatwrap was temporarily withdrawn.The adverse events did diminish after withdrawal and the events did not re-occur after re-administration.Therapeutic measures taken included "hydrocolloid patch/gel, ointment (containing iodine).Surgical intervention, such as debridement, was not required.Long-term sequelae such as scarring was not expected.Clinical outcome of the events was resolved "three weeks later".The reporting other hcp assessed the causality relationship of the events with the suspect product as related.Additional information has been requested and will be provided as it becomes available.Follow-up (07jun2017): new information received from the same other hcp includes: patient details, past medical history, concomitant medications, past product history, action taken with suspect product, reaction data (additional events of discomfort, sweating and open wound), therapeutic measures taken and other hcp causal relationship.This case has been upgraded to a serious reportable medical device report.Company clinical evaluation comment: based on the information provided, the events of "burn spots on the back the size of a fifty cent coin similar in size to the iron cells", "open and red exuding wounds", "from saturday midday to sunday morning with instructions to change the wrap every 8 hours" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.All other events are assessed as non serious.All the events are medically assessed as associated with the use of the device., comment: based on the information provided, the events of "burn spots on the back the size of a fifty cent coin similar in size to the iron cells", "open and red exuding wounds", "from saturday midday to sunday morning with instructions to change the wrap every 8 hours" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.All other events are assessed as non serious.All the events are medically assessed as associated with the use of the device.
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Manufacturer Narrative
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The root cause category is non-assignable (complaint not confirmed).The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.
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Event Description
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Event verbatim [preferred term] burn spots on the back the size of a fifty cent coin similar in size to the "iron cells" [thermal burn], open and red exuding wounds [wound], from saturday midday to sunday morning with instructions to change the wrap every 8 hours (approximately 12 hours) [intentional device use issue], new material is uncomfortable [discomfort], sweating [hyperhidrosis], material is not as good as before, the belt was twisting, the material no longer had a correct suction while sweating [device material issue].Case narrative: this is a spontaneous report from a contactable other health professional communicated to a company representative.A (b)(6) female patient of an unspecified ethnicity started to use thermacare heatwrap (thermacare lower back and hip) (device lot number: n73395, expiration date jul2019) from an unspecified date for an unspecified indication.The patient's medical history included cat allergy, house dust allergy, hay fever, heart disease from an unspecified date and ongoing and heart attack in (b)(6) 2015.Concomitant medications included bisoprolol, ass, atorvastatin, ramipril and jodid.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.The patient reported she used the heatwrap from saturday midday to sunday morning despite instructions to change the wrap every 8 hours (used heatwrap approximately 12 hours) and experienced burn spots on the back the size of a fifty cent coin similar in size to the "iron cells" with open and red exuding wounds on an unspecified date.The patient had administered the product for years and was of the opinion that the material was not as good as before.She further stated that the belt was twisting, the material no longer had a correct suction while sweating etc.The patient reported the new material causes heat accumulation (meaning the material does not absorb the water), is uncomfortable and not skin-friendly.She stated in the past the material felt comfortable and did absorb the sweat.Action taken in response to the events for thermacare heatwrap was temporarily withdrawn.The adverse events did diminish after withdrawal and the events did not re-occur after re-administration.Therapeutic measures taken included "hydrocolloid patch/gel, ointment (containing iodine).Surgical intervention, such as debridement, was not required.Long-term sequelae such as scarring was not expected.Clinical outcome of the events was resolved "three weeks later".The reporting other hcp assessed the causality relationship of the events with the suspect product as related.Additional information received from product quality complaint (pqc) group included investigation results.The root cause category is non-assignable (complaint not confirmed).The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Additional information has been requested and will be provided as it becomes available.Follow-up (07jun2017): new information received from the same other hcp includes: patient details, past medical history, concomitant medications, past product history, action taken with suspect product, reaction data (additional events of discomfort, sweating and open wound), therapeutic measures taken and other hcp causal relationship.This case has been upgraded to a serious reportable medical device report.Follow-up (22jun2017): new information received from product quality complaints (pqc) group included: product quality investigation results.Company clinical evaluation comment based on the information provided, the events of "burn spots on the back the size of a fifty cent coin similar in size to the iron cells", "open and red exuding wounds", "from saturday midday to sunday morning with instructions to change the wrap every 8 hours" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.All other events are assessed as non serious.All the events are medically assessed as associated with the use of the device.Case closed.Follow-up attempts completed.No further information expected.Comment: based on the information provided, the events of "burn spots on the back the size of a fifty cent coin similar in size to the iron cells", "open and red exuding wounds", "from saturday midday to sunday morning with instructions to change the wrap every 8 hours" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.All other events are assessed as non serious.All the events are medically assessed as associated with the use of the device.
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Event Description
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Event verbatim [preferred term] burn spots on the back the size of a fifty cent coin similar in size to the "iron cells" [:thermal burn] , open and red exuding wounds [wound] , from saturday midday to sunday morning with instructions to change the wrap every 8 hours (approximately 12 hours) [intentional device use issue] , new material is uncomfortable [discomfort] , sweating [hyperhidrosis] , material is not as good as before, the belt was twisting, the material no longer had a correct suction while sweating [device material issue].Case narrative:this is a spontaneous report from a contactable other health professional communicated to a company representative.A 52-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip) (device lot number: n73395, expiration date jul2019) from an unspecified date for back pain.The patient's medical history included cat allergy, house dust allergy, hay fever, heart disease from an unspecified date and ongoing and heart attack in (b)(6)2015.Concomitant medications included bisoprolol, acetylsalicylic acid (ass), atorvastatin, ramipril and potassium iodide (jodid).Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.The patient reported she used the heatwrap from saturday midday to sunday morning despite instructions to change the wrap every 8 hours (used heatwrap approximately 12 hours) and experienced burn spots on the back the size of a fifty cent coin similar in size to the "iron cells" with open and red exuding wounds on an unspecified date.The patient had administered the product for years and was of the opinion that the material was not as good as before.She further stated that the belt was twisting, the material no longer had a correct suction while sweating etc.The patient reported the new material causes heat accumulation (meaning the material does not absorb the water), is uncomfortable and not skin-friendly.She stated in the past the material felt comfortable and did absorb the sweat.Action taken in response to the events for thermacare heatwrap was temporarily withdrawn.The adverse events "burn with wound" did diminish after withdrawal and the events did not re-occur after re-administration.Therapeutic measures taken for "burn with wound" included "hydrocolloid patch/gel, ointment (containing iodine).Surgical intervention, such as debridement, was not required.Long-term sequelae such as scarring was not expected.Clinical outcome of the events "burn with wound" was resolved "three weeks later".The outcome of the other events was resolved on unknown date.The reporting other hcp assessed the causality relationship of the events with the suspect product as related.Additional information received from product quality complaint (pqc) group included investigation results.The root cause category is non-assignable (complaint not confirmed).The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Follow-up (07jun2017): new information received from the same other hcp includes: patient details, past medical history, concomitant medications, past product history, action taken with suspect product, reaction data (additional events of discomfort, sweating and open wound), therapeutic measures taken and other hcp causal relationship.This case has been upgraded to a serious reportable medical device report.Follow-up (22jun2017): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up attempts completed.No further information expected.Amendment: this follow-up report is being submitted to amend previously reported information: product indication "back pain" added in narrative.Company clinical evaluation comment based on the information provided, the events of "burn spots on the back the size of a fifty cent coin similar in size to the iron cells", "open and red exuding wounds", "from saturday midday to sunday morning with instructions to change the wrap every 8 hours" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.All other events are assessed as non serious.All the events are medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.In the case narrative there is evidence of "from saturday midday to sunday morning with instructions to change the wrap every 8 hours" which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the events of "burn spots on the back the size of a fifty cent coin similar in size to the iron cells", "open and red exuding wounds", "from saturday midday to sunday morning with instructions to change the wrap every 8 hours" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.All other events are assessed as non serious.All the events are medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.In the case narrative there is evidence of "from saturday midday to sunday morning with instructions to change the wrap every 8 hours" which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Manufacturer Narrative
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The root cause category is non-assignable (complaint not confirmed).The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.
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Search Alerts/Recalls
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