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| Device Problem
Leak/Splash (1354)
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| Patient Problems
Erythema (1840); Patient Problem/Medical Problem (2688)
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Event Type
malfunction
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Manufacturer Narrative
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The complaint narrative represents a potential device malfunction.The severity level is s3 per (b)(4) "bridging pfizer hal severity ranking to severity numbers applied in the thermacare heat wrap rmp".A return sample was not received, batch number was not available; a device malfunction cannot be confirmed.There is no further investigation or actions needed.The root cause category is non-assignable (complaint not confirmed).Our manufacturing operations employ quality control procedures which include in-process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.There is not a trend identified for the subclass cells damaged/leaking for nsw8 products, refer to the attached trend chart for may2016-may2019.There is no further investigation or action required.
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Event Description
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Event verbatim [preferred term] had red marks that looked like chemical burns [chemical burn of skin] , exploded [device leakage] ,.Case narrative:this is a spontaneous report from a contactable consumer reporting for her niece.This female patient of unknown age started to use thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number not provided) from an unknown date for an unknown indication.The patient's medical history and concomitant medications were not reported.On an unspecified date, the reporter stated she shared a heatwrap with her niece and the one she used exploded.The niece had red marks that looked like chemical burns.Action taken with the suspect product was unknown.Clinical outcome of the events was unknown.Additional information received from product quality complaint (pqc) group included investigation results.The complaint narrative represents a potential device malfunction.The severity level is s3 per (b)(4) "bridging pfizer hal severity ranking to severity numbers applied in the thermacare heat wrap rmp".A return sample was not received, batch number was not available; a device malfunction cannot be confirmed.There is no further investigation or actions needed.The root cause category is non-assignable (complaint not confirmed).Our manufacturing operations employ quality control procedures which include in-process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.There is not a trend identified for the subclass cells damaged/leaking for nsw8 products, refer to the attached trend chart for may2016-may2019.There is no further investigation or action required.Company clinical evaluation comment: based on available information, the reported explosion of the device was associated with the red marks that looked like chemical burns, and represents a potential device malfunction.There was limited device specific information provided, no batch number or return sample was available for evaluation; a device malfunction cannot be confirmed.There is not a trend identified for the subclass cells damaged/leaking for nsw8 products.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on available information, the reported explosion of the device was associated with the red marks that looked like chemical burns, and represents a potential device malfunction.There was limited device specific information provided, no batch number or return sample was available for evaluation; a device malfunction cannot be confirmed.There is not a trend identified for the subclass cells damaged/leaking for nsw8 products.Product effect varies with each individual.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 complaint narrative represents a potential device malfunction.The severity level is s3 per rpt-74091 "bridging pfizer hal severity ranking to severity numbers applied in the thermacare heat wrap rmp".A return sample was not received, batch number was not available; a device malfunction cannot be confirmed.There is no further investigation or actions needed.The root cause category is non-assignable (complaint not confirmed).Our manufacturing operations employ quality control procedures which include in-process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.There is not a trend identified for the subclass cells damaged/leaking for nsw8 products, refer to the attached trend chart for (b)(6) 2016-(b)(6) 2019.There is no further investigation or action required.Additional information received on 28aug2019 from product quality complaint (pqc) group included investigation results.The root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adhesion/fastening defect.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.
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Event Description
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Event verbatim [preferred term] had red marks that looked like chemical burns [chemical burn of skin] , exploded [device leakage] ,.Case narrative:this is a spontaneous report from a contactable consumer reporting for her niece.This female patient of unknown age started to use thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number not provided) from an unknown date for an unknown indication.The patient's medical history and concomitant medications were not reported.On an unspecified date, the reporter stated she shared a heatwrap with her niece and the one she used exploded.The niece had red marks that looked like chemical burns.Action taken with the suspect product was unknown.Clinical outcome of the events was unknown.Additional information received from product quality complaint (pqc) group included investigation results.The complaint narrative represents a potential device malfunction.The severity level is s3 per rpt-74091 "bridging pfizer hal severity ranking to severity numbers applied in the thermacare heat wrap rmp".A return sample was not received, batch number was not available; a device malfunction cannot be confirmed.There is no further investigation or actions needed.The root cause category is non-assignable (complaint not confirmed).Our manufacturing operations employ quality control procedures which include in-process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.There is not a trend identified for the subclass cells damaged/leaking for nsw8 products, refer to the attached trend chart for may2016-may2019.There is no further investigation or action required.Additional information received on 28aug2019 from product quality complaint (pqc) group included investigation results.The root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adhesion/fastening defect.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Follow-up (06jul2019): follow-up attempts are completed.No further information is expected.Follow-up (28aug2019): new information received from product quality complaints (pqc) group included: additional product quality investigation results.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment based on available information, the reported explosion of the device was associated with the red marks that looked like chemical burns, and represents a potential device malfunction.There was limited device specific information provided, no batch number or return sample was available for evaluation; a device malfunction cannot be confirmed.There is not a trend identified for the subclass cells damaged/leaking for nsw8 products.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on available information, the reported explosion of the device was associated with the red marks that looked like chemical burns, and represents a potential device malfunction.There was limited device specific information provided, no batch number or return sample was available for evaluation; a device malfunction cannot be confirmed.There is not a trend identified for the subclass cells damaged/leaking for nsw8 products.Product effect varies with each individual.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 complaint narrative represents a potential device malfunction.The severity level is s3 per rpt-74091 "bridging pfizer hal severity ranking to severity numbers applied in the thermacare heat wrap rmp".A return sample was not received, batch number was not available; a device malfunction cannot be confirmed.There is no further investigation or actions needed.The root cause category is non-assignable (complaint not confirmed).Our manufacturing operations employ quality control procedures which include in-process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.There is not a trend identified for the subclass cells damaged/leaking for nsw8 products, refer to the attached trend chart for (b)(6)2016-(b)(6)2019.There is no further investigation or action required.Additional information received on (b)(6)2019 from product quality complaint (pqc) group included investigation results.The root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adhesion/fastening defect.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.There is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per rpt- 38832 hazard analysis thermacare heat wrap product: 8 and 12 hour.Please evaluate for mdr.The site investigation is in process.
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Event Description
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Event verbatim [preferred term] had red marks that looked like chemical burns [chemical burn of skin] , exploded [device leakage] ,.Case narrative:this is a spontaneous report from a contactable consumer reporting for her niece.This female patient of unknown age started to use thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number not provided) from an unknown date for an unknown indication.The patient's medical history and concomitant medications were not reported.On an unspecified date, the reporter stated she shared a heatwrap with her niece and the one she used exploded.The niece had red marks that looked like chemical burns.Action taken with the suspect product was unknown.Clinical outcome of the events was unknown.Additional information received from product quality complaint (pqc) group included investigation results.The complaint narrative represents a potential device malfunction.The severity level is s3 per rpt-74091 "bridging pfizer hal severity ranking to severity numbers applied in the thermacare heat wrap rmp".A return sample was not received, batch number was not available; a device malfunction cannot be confirmed.There is no further investigation or actions needed.The root cause category is non-assignable (complaint not confirmed).Our manufacturing operations employ quality control procedures which include in-process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.There is not a trend identified for the subclass cells damaged/leaking for nsw8 products, refer to the attached trend chart for may2016-may2019.There is no further investigation or action required.Additional information received on 05sep2019 from product quality complaint (pqc) group included investigation results.The root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adhesion/fastening defect.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.There is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per rpt- 38832 hazard analysis thermacare heat wrap product: 8 and 12 hour.Please evaluate for mdr.The site investigation is in process.Follow-up (06jul2019): follow-up attempts are completed.No further information is expected.Follow-up (28aug2019): new information received from product quality complaints (pqc) group included: additional product quality investigation results.Follow-up attempts are completed.No further information is expected.Follow-up (05sep2019): new information received from product quality complaints (pqc) group included: investigation results, severity ranking and impact analysis.Company clinical evaluation comment based on available information, the reported explosion of the device was associated with the red marks that looked like chemical burns, and represents a potential device malfunction.There was limited device specific information provided, no batch number or return sample was available for evaluation; a device malfunction cannot be confirmed.There is not a trend identified for the subclass cells damaged/leaking for nsw8 products.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on available information, the reported explosion of the device was associated with the red marks that looked like chemical burns, and represents a potential device malfunction.There was limited device specific information provided, no batch number or return sample was available for evaluation; a device malfunction cannot be confirmed.There is not a trend identified for the subclass cells damaged/leaking for nsw8 products.Product effect varies with each individual.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 complaint narrative represents a potential device malfunction.The severity level is s3 per rpt-74091 "bridging pfizer hal severity ranking to severity numbers applied in the thermacare heat wrap rmp".A return sample was not received, batch number was not available; a device malfunction cannot be confirmed.There is no further investigation or actions needed.The root cause category is non-assignable (complaint not confirmed).Our manufacturing operations employ quality control procedures which include in-process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.There is not a trend identified for the subclass cells damaged/leaking for nsw8 products, refer to the attached trend chart for (b)(6)2016-(b)(6)2019.There is no further investigation or action required.Additional information received from product quality complaint (pqc) group included investigation results.The root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclasses: adhesion/fastening defect, adverse event/serious/unknown, and adverse event safety request for investigation.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.There is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per rpt- 38832 hazard analysis thermacare heat wrap product: 8 and 12 hour.
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Event Description
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Event verbatim [preferred term] had red marks that looked like chemical burns [chemical burn of skin] , exploded [device leakage] ,.Case narrative:this is a spontaneous report from a contactable consumer reporting for her niece.This female patient of unknown age started to use thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number not provided) from an unknown date for an unknown indication.The patient's medical history and concomitant medications were not reported.On an unspecified date, the reporter stated she shared a heatwrap with her niece and the one she used exploded.The niece had red marks that looked like chemical burns.Action taken with the suspect product was unknown.Clinical outcome of the events was unknown.Additional information received from product quality complaint (pqc) group included investigation results.The complaint narrative represents a potential device malfunction.The severity level is s3 per rpt-74091 "bridging pfizer hal severity ranking to severity numbers applied in the thermacare heat wrap rmp".A return sample was not received, batch number was not available; a device malfunction cannot be confirmed.There is no further investigation or actions needed.The root cause category is non-assignable (complaint not confirmed).Our manufacturing operations employ quality control procedures which include in-process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.There is not a trend identified for the subclass cells damaged/leaking for nsw8 products, refer to the attached trend chart for may2016-may2019.There is no further investigation or action required.Additional information received from product quality complaint (pqc) group included investigation results.The root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclasses: adhesion/fastening defect, adverse event/serious/unknown, and adverse event safety request for investigation.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.There is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per rpt- 38832 hazard analysis thermacare heat wrap product: 8 and 12 hour.Follow-up (06jul2019): follow-up attempts are completed.No further information is expected.Follow-up (28aug2019): new information received from product quality complaints (pqc) group included: additional product quality investigation results.Follow-up attempts are completed.No further information is expected.Follow-up (05sep2019): new information received from product quality complaints (pqc) group included: investigation results, severity ranking and impact analysis.Follow-up (06sep2019): new information received from product quality complaints (pqc) group included: additional investigation results.Company clinical evaluation comment based on available information, the reported explosion of the device was associated with the red marks that looked like chemical burns, and represents a potential device malfunction.There was limited device specific information provided, no batch number or return sample was available for evaluation; a device malfunction cannot be confirmed.There is not a trend identified for the subclass cells damaged/leaking for nsw8 products.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on available information, the reported explosion of the device was associated with the red marks that looked like chemical burns, and represents a potential device malfunction.There was limited device specific information provided, no batch number or return sample was available for evaluation; a device malfunction cannot be confirmed.There is not a trend identified for the subclass cells damaged/leaking for nsw8 products.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Search Alerts/Recalls
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