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PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAPS MULTI-PURPOSE MUSCLE PAIN; DISPOSABLE PACK, HOT
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| Lot Number S41968 |
| Device Problem
Human-Device Interface Problem (2949)
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| Patient Problem
Burn, Thermal (2530)
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| Event Date 11/01/2018 |
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Event Type
Injury
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Event Description
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Felt like she was getting burned/1 inch long red area/3 blisters/area is still tender/redness and irritated skin [burns second degree].Used on across her bladder area/attached to the skin/did not check skin/did not read instructions [device use error].Used for flare up of interstitial cystitis [device use issue].Case narrative: this is a spontaneous report from a contactable consumer.A (b)(6) female patient started to receive thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain), device lot number s41968, expiration date mar2020, via an unspecified route of administration from an unspecified date for cystitis interstitial.She is currently under the care of a physician for her flare ups with interstitial cystitis by "an" urologist.Medical history included appendix removed when she was younger.The patient was taking other unspecified medications during the time the problem/symptom was experienced.The patient said she was told by her urologist to use this product for her problem and flare ups with interstitial cystitis and has been using for 4 years.She applies the heatwrap just above her pubic bone horizontally across her bladder area.About a week ago in (b)(6) 2018 she applied it that morning and after a couple of hours (between 6 to 8 hours) later that day her skin became uncomfortable and felt like she was getting burned so she took it off and looked at the area.There was a 1 inch long red area, there were 3 blisters, and in the middle was a scab, but it is not healing.The patient treated the area herself by applying a natural cream ointment and applied a band-aid so that the scab could stay moistened.When she took off the band-aid this morning it hadn't softened the scab at all.The other two areas had no scab, but the area in the middle hadn't changed since she took off the wrap.The patient states she is not going to discontinue the product because it was very comforting with her flare ups.The area is still tender when she touches it and irritated and red, but no open spaces in there.She still has the injury with the scab, redness and irritated skin.Patient classifies skin tone as very fair and has sensitive skin, but no abnormal skin condition.The patient has previously used thermacare about 3-4 weeks ago generally up to 8 hours, and has not experienced the same problem/symptom during previous use.The patient has also previously used other heat products for about 30 minutes and never had problem with heating pad.She was not wearing the product while sleeping.She was wearing several layers of clothing over the thermacare product and was wearing underwear and jeans but they were not tight.The patient attached the adhesive to her body as there are tabs on each side so it can be attached to skin.She did not engage in exercise while using the product, did not check her skin under the product while wearing thermacare, and did not read the usage instructions on thermacare before using the product.The action taken in response to the event for thermacare heatwrap was: dose not changed.The outcome of the events is not recovered.The patient discarded the product.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the event of "burns second degree and device use error" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The "events" "device use issue" is assessed as non-serious.The events are medically assessed as associated with the use of the device.
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Manufacturer Narrative
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Batch: s41968 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of retain samples included four cartons, 12 pouches and 12 pouch wraps inside.Inspection shows no obvious defects to cartons.Two of the 12 pouches had an incomplete long seal, allowing the wraps inside to activate and exhaust inside the pouch.(investigation: (b)(4) for open long seals resulted in eight capa items being completed for long seal defects.) there were no obvious defects to the wraps; there was no cell pack damage or leaking.Form-46455 retain sample inspection form documented the retain evaluation performed on (b)(6) 2018 for an unrelated complaint.An evaluation of the complaint history confirms that this is the fourth complaint for the sub class adverse event safety request for investigation received at the (place name) site requiring an evaluation for this batch.The previous complaints were not confirmed to have a manufacturing related root cause for the complaint.On the basis of this evaluation, a trend does not exist for this batch.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects recorded for the batch.Thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6 c - 41.6 c) per muscle and joint, spec-22096, effective: 28nov2016.Review of the packaging attributes (pouch, carton, and shipper container) quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria was met.There were no pack attribute defects recorded for the batch.A total of 3024 pti (pouch leak) tests were performed with 11 fa.
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Event Description
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Felt like she was getting burned/ 1 inch long red area/ 3 blisters/ area is still tender/ redness and irritated skin [burns second degree], in the middle was a scab, but it is not healing.[scar] , used on across her bladder area/ attached to the skin/ did not check skin/ did not read instructions [device use error], used for flare up of interstitial cystitis [device use issue].Case narrative: this is a spontaneous report from a contactable consumer.A 73-year-old female patient started to receive thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain), device lot number: s41968, expiration date mar2020, from an unspecified date at unknown frequency for cystitis interstitial.She is currently under the care of a physician for her flare ups with interstitial cystitis by an urologist.Medical history included appendix removed when she was younger.The patient was taking other unspecified medications during the time the problem/symptom was experienced.The patient said she was told by her urologist to use this product for her problem and flare ups with interstitial cystitis and has been using for 4 years.She applies the heatwrap just above her pubic bone horizontally across her bladder area.About a week ago in nov2018 she applied it that morning and after a couple of hours (between 6 to 8 hours) later that day her skin became uncomfortable and felt like she was getting burned so she took it off and looked at the area.There was a 1 inch long red area, there were 3 blisters, and in the middle was a scab, but it is not healing.The patient treated the area herself by applying a natural cream ointment and applied a band-aid so that the scab could stay moistened.When she took off the band-aid this morning it hadn't softened the scab at all.Patient declined to provide the natural ointment details used.The other two areas had no scab, but the area in the middle hadn't changed since she took off the wrap.The patient states she is not going to discontinue the product because it was very comforting with her flare ups.The area is still tender when she touches it and irritated and red, but no open spaces in there.She still has the injury with the scab, redness and irritated skin.Patient classifies skin tone as very fair and has sensitive skin, but no abnormal skin condition.The patient has previously used thermacare about 3 -4 weeks ago generally up to 8 hours, and has not experienced the same problem/symptom during previous use.The patient has also previously used other heat products for about 30 minutes and never had problem with heating pad.She was not wearing the product while sleeping.She was wearing several layers of clothing over the thermacare product and was wearing underwear and jeans but they were not tight.The patient attached the adhesive to her body as there are tabs on each side so it can be attached to skin.She did not engage in exercise while using the product, did not check her skin under the product while wearing thermacare, and did not read the usage instructions on thermacare before using the product.The action taken in response to the event for thermacare heatwrap was dose not changed.The outcome of the events is not recovered.The patient discarded the product.Conclusion from the product quality complaint group included: batch: s41968 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of retain samples included four cartons, 12 pouches and 12 pouch wraps inside.Inspection shows no obvious defects to cartons.Two of the 12 pouches had an incomplete long seal, allowing the wraps inside to activate and exhaust inside the pouch.(investigation: (b)(4) for open long seals resulted in eight capa items being completed for long seal defects.) there were no obvious defects to the wraps; there was no cell pack damage or leaking.Form-46455 retain sample inspection form documented the retain evaluation performed on (b)(6) 2018 for an unrelated complaint.An evaluation of the complaint history confirms that this is the fourth complaint for the sub class adverse event safety request for investigation received at the (place name) site requiring an evaluation for this batch.The previous complaints were not confirmed to have a manufacturing related root cause for the complaint.On the basis of this evaluation, a trend does not exist for this batch.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects recorded for the batch.Thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6 c - 41.6 c) per muscle and joint, spec-22096, effective: 28nov2016.Review of the packaging attributes (pouch, carton, and shipper container) quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria was met.There were no pack attribute defects recorded for the batch.A total of 3024 pti (pouch leak) tests were performed with 11 failures.Pouch leak maximum acceptance limit for a sample size of 2980 pti tests is 52 failures per cd-40761 pouch leak test sampling plan extension, effective date: 06mar2017.Review of the shiftily production transition notes did not note any issues in the heat pack maker or flow wrappers that would affect wrap temperatures.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap temperatures.Investigation summary: the root cause category is non assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports "there was a 1 inch long red area and there were 3 blisters" after wearing a wrap "a couple of hours ".The cause of the 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 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.The product quality for the batch is not impacted by this complaint.Follow-up (03jan2019): new information received from product quality complaints included: investigational results.Company clinical evaluation comment: based on the information provided, the event of "burns second degree, scar and device use error" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event device use issue is assessed as non-serious.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.No remedial action/corrective action/field safety corrective action is suggested at this time.Comment: based on the information provided, the event of "burns second degree, scar and device use error" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event device use issue is assessed as non-serious.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.No remedial action/corrective action/field safety corrective action is suggested at this time.
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