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PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAPS MULTI-PURPOSE JOINT PAIN; DISPOSABLE PACK, HOT
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| Lot Number J47186 |
| Device Problem
Device Handling Problem (3265)
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| Patient Problems
Purulent Discharge (1812); Unspecified Infection (1930); Partial thickness (Second Degree) Burn (2694)
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| Event Date 06/14/2016 |
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Event Type
Injury
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Event Description
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Burned all across lower back-2nd degree, almost 3rd degree burn [burns second degree].That is open and has pus [wound infection].Applied to lumbar area for disc issue, did not check skin under the product while wearing thermacare [intentional device misuse].Case description: this is a spontaneous report from a contactable consumer reported for his wife.A (b)(6) caucasian female patient, not pregnant started to receive thermacare heatwrap (thermacare heatwraps multi-purpose joint pain) , device lot number j47186 , expiration date jul2017 , from many years, applied to lumbar area for disc issue and arthritis.Medical history included arthritis from 2015, thyroid disorder from 2015.Post-menopausal.Concomitant medication included levothyroxine sodium (synthroid) since 2015 for thyroid.Probably 3 months ago in (b)(6) 2016 used unspecified other heat products for pain relief, no adverse event occurred with one of these products.The patient may use 3-4 days then stop when having issues with disc, puts right on back and had on for 8 hours while at work.Did not check skin under the product while wearing thermacare; read the usage instructions on thermacare before used the product; it burned her back.It is all across her back and is second degree, almost 3rd degree burn.Caller states that the product is definitely a defective product.Caller described the burn as a big red blotch, about 4 inches wide.It is raised and has one area the size of a dime that is open and has pus.The area that opened was white and then oozed.This was thought to have happened on friday (b)(6) 2016.Did not experience same problem during previous use.By the time of report, the open area has improved but it remains reddened.Did not contact hcp, but did show it to the chiropractor.Chiropractor advised to apply neosporin to open area.She was applying the neosporin on that area.Skin tone was very light or fair, no sensitive skin; has no abnormal skin conditions; did not engage in exercise while using the product.The events burn and pus were resolving by the time of report, the other event outcome was unknown.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment based on the information provided, the events burns second degree, wound infection, and intentional device misuse 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.This case meets initial 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events burns second degree, wound infection, and intentional device misuse 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.This case meets initial 10-day eu and 30-day fda reportability.
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Manufacturer Narrative
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The root cause category is non assignable (complaint not confirmed).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.The plant has reviewed this batch from a manufacturing and technical 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.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.
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Event Description
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Case description: this is a spontaneous report from a contactable consumer reported for his wife.A (b)(6) caucasian female patient, not pregnant started to use thermacare heatwrap (thermacare heatwraps multi-purpose joint pain) (device lot number: j47186, expiration date: jul2017) from many years for lower back pain of associated sciatic radiation into left ischium and arthritis.The patient's medical history included arthritis from 2015, thyroid disorder from 2015 and post-menopausal from an unspecified date.Concomitant medication included ongoing levothyroxine sodium (synthroid) since 2015 for thyroid disorder.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.On (b)(6) 2016, the patient reported she had the heatwrap on for 8 hours while at work and it burned her back.It is all across her back and is second degree, almost 3rd degree burn.The patient stated the product is definitely a defective product.She described the burn as a big red blotch, about 4 inches wide.It is raised and has one area the size of a dime.On (b)(6) 2016, the patient reported the burn was open and had pus.The area that opened was white and then oozed.She stated the open area has improved but it remains reddened.The patient did not contact a healthcare professional, but did show it to a chiropractor.The chiropractor advised her to apply neosporin to the open area.The patient assessed her skin tone as very light or fair.She denied having sensitive skin and had no abnormal skin conditions.The patient may use heatwraps for 3-4 days then stop when having issues with disc.She then puts the heatwrap right on back.She did not check skin under the product while wearing thermacare.The patient stated she read the usage instructions on thermacare before used the product.She did not engage in exercise while using the product.Action taken with the suspect product was permanently withdrawn on an unspecified date.Therapeutic measures taken included over-the-counter pain medications (ibuprofen) and applying antibiotic ointment/cream (neosporin) to blisters.Clinical outcome of the events burn and pus were resolving.Clinical outcome of the other events was unknown.Additional information received on 21jul2016 from a contactable physician included: the physician considered thermacare heatwrap had a causal effect to the adverse event.The physician reported the event was second degree burns noted to both outer and underlying layer of skin across small of the back bilaterally with blistering, swelling and pain.Focal blistering and scarring noted also right side of crest of ilium.Pigment changes and fibrinous exudate noted.No hospitalization was required as a result of the events.No surgery or surgical debridement was required.The physician reported long-term sequelae such as scarring were expected.Pigment changes are noted across the entire small of back and scarring expected towards right side adjacent lines along crest of ilium.Clinical outcome of the events was reported as recovered with sequelae.According to the product quality complaint group: the root cause category is non assignable (complaint not confirmed).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.The plant has reviewed this batch from a manufacturing and technical 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.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.Additional information has been requested and will be provided as it becomes available.Follow up (21jul2016): new information received from a contactable physician includes: updated suspect product indication, action taken with suspect product, updated event onset date, reaction data (additional events of scarring and pigment changes) physician's causality assessment, medical confirmation of the report, additional therapeutic measures taken and no hospitalization or surgical intervention required.Follow-up (04aug2016): new information received from the product quality complaint group included investigational results.Company clinical evaluation comment: based on the information provided, the events burns second degree, wound infection, and intentional device misuse 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 added events skin discoloration and scar are assessed as associated with the device use.This case meets final 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events burns second degree, wound infection, and intentional device misuse 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 added events skin discoloration and scar are assessed as associated with the device use.This case meets final 10-day eu and 30-day fda reportability.Evaluation summary the root cause category is non assignable (complaint not confirmed).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.The plant has reviewed this batch from a manufacturing and technical 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.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.
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Event Description
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Second degree burns noted to both outer and underlying layer of skin across small of the back bilaterally with blistering, swelling and pain [burns second degree].That is open and has pus [wound infection].Did not check skin under the product while wearing thermacare [intentional device misuse].Pigment changes and fibrinous exudate noted [skin discolouration].Scarring noted also right side of crest of ilium [scar].Case description: this is a spontaneous report from a contactable consumer reported for his wife.A (b)(6) female patient, not pregnant started to use thermacare heatwrap (thermacare heatwraps multi-purpose joint pain) (device lot number: j47186, expiration date: jul 2017) from many years for lower back pain of associated sciatic radiation into left ischium and arthritis.The patient's medical history included arthritis from 2015, thyroid disorder from 2015 and post-menopausal from an unspecified date.Concomitant medication included ongoing levothyroxine sodium (synthroid) since 2015 for thyroid disorder.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.On (b)(6) 2016, the patient reported she had the heatwrap on for 8 hours while at work and it burned her back.It is all across her back and is second degree, almost 3rd degree burn.The patient stated the product is definitely a defective product.She described the burn as a big red blotch, about 4 inches wide.It is raised and has one area the size of a dime.On (b)(6) 2016, the patient reported the burn was open and had pus.The area that opened was white and then oozed.She stated the open area has improved but it remains reddened.The patient did not contact a healthcare professional, but did show it to a chiropractor.The chiropractor advised her to apply neosporin to the open area.The patient assessed her skin tone as very light or fair.She denied having sensitive skin and had no abnormal skin conditions.The patient may use heatwraps for 3-4 days then stop when having issues with disc.She then puts the heatwrap right on back.She did not check skin under the product while wearing thermacare.The patient stated she read the usage instructions on thermacare before used the product.She did not engage in exercise while using the product.Action taken with the suspect product was permanently withdrawn on an unspecified date.Therapeutic measures taken included over-the-counter pain medications (ibuprofen) and applying antibiotic ointment/cream (neosporin) to blisters.Clinical outcome of the events burn and pus were resolving.Clinical outcome of the other event was unknown.Additional information received on 21jul2016 from a contactable physician included: the physician considered thermacare heatwrap had a causal effect to the adverse event.The physician reported the event was second degree burns noted to both outer and underlying layer of skin across small of the back bilaterally with blistering, swelling and pain.Focal blistering and scarring noted also right side of crest of ilium.Pigment changes and fibrinous exudate noted.No hospitalization was required as a result of the events.No surgery or surgical debridement was required.The physician reported long-term sequelae such as scarring were expected.Pigment changes are noted across the entire small of back and scarring expected towards right side adjacent lines along crest of ilium.Clinical outcome of the events was reported as recovered with sequelae.Additional information has been requested and will be provided as it becomes available.Follow up (21jul2016): new information received from a contactable physician includes: updated suspect product indication, action taken with suspect product, updated event onset date, reaction data (additional events of scarring and pigment changes) physician's causality assessment, medical confirmation of the report, additional therapeutic measures taken and no hospitalization or surgical intervention required.Company clinical evaluation comment: based on the information provided, the events burns second degree, wound infection, and intentional device misuse 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 added events skin discoloration and scar are assessed as associated with the device use.This case meets follow up 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events burns second degree, wound infection, and intentional device misuse 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 added events skin discoloration and scar are assessed as associated with the device use.This case meets follow up 10-day eu and 30-day fda reportability.
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