MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE NECK, SHOULDER & WRIST; DISPOSABLE PACK, HOT

PFIZER CONSUMER HEALTH CARE THERMACARE NECK, SHOULDER & WRIST; DISPOSABLE PACK, HOT

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Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abrasion (1689); Dehydration (1807); Erythema (1840); Pain (1994); Tissue Breakdown (2681)

Event Date 11/01/2016

Event Type Injury

Event Description

Manufacturer Narrative

This investigation was conducted for an unknown lot number arthritis neck/shoulder/wrist (nsw) 12 hour product.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 trend identified related for the subclass adverse event safety request for investigation.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage, and investigation (citi) customizable search was performed: scope: date contacted: 11/04/2013 through 11/04/2016/manufacturing site: pfizer albany/complaint class: external cause investigation / complaint sub class: adverse event safety request for investigation.The citi customizable search returned a total of 15 complaints for arthritis neck/shoulder/wrist (nsw) 12hr products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.Adverse event safety request for investigation and adverse event negligible-minor.The data shows an increase of complaints received for the subclass in june 2016.All 3 complaints received in june were related to burns, blister and redness.The data did not show an increase over time (36 months).There is not a trend identified for the subclass adverse event safety request for investigation, adverse event safety request for investigation and adverse event negligible-minor for arthritis nsw 12hr products, refer to the attached trend chart for 04 november 2013 to 04 november 2016.There is no further action required.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.

Event Description

Event verbatim [preferred term] skin peeled [skin exfoliation] , superficial skin abrasion [skin abrasion] , heat-induced like skin reaction [skin reaction] , heat-induced like skin reaction at the site where heatwrap was administered/ print of the adhesive strips on the skin of the neck [application site reaction] , red, rough skin/red, rough and painful skin [erythema] , red, rough skin/red, rough and painful skin [dry skin] , the skin was rough and painful/red, rough and painful skin [pain of skin].Case narrative:this is a spontaneous report from a contactable consumer.A 39-year-old female patient started to use thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number not reported) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.On an unspecified date in (b)(6) 2016, the patient reported she administered the thermacare heatwrap during day time and took it off before sleeping.On the following morning she recognized a heat-induced like skin reaction at the site where she had administered the heatwrap the day before.The patient stated her skin was red and rough and she developed a superficial skin abrasion.The patient further reported that she suffered from a print of the adhesive strips on the neck.The problem of the patient was definitely due to the print and not due to the fact that the thermacare was too hot.The skin was rough and painful and the patient could not use a scarf.Her pharmacist said to her that the print was very strong and looked like a heat - induced reaction.She got an ointment and this ointment worked very well and within 2 days all events disappeared.The skin was very rough and it was likely that the skin peeled but there was no blister there.The patient did not visit a doctor.The patient did not suffer from sensible skin, skin diseases or from diabetes.In the past she used thermacare heatwrap without any problems for a maximum time period of five hours, as she did this time.She never slept on thermacare heatwrap.Action taken with the suspect product was unknown.Therapeutic measures taken included an unspecified ointment.Clinical outcome of the events was resolved in (b)(6) 2016.Additional information received from product quality complaint (pqc) group included investigation results.This investigation was conducted for an unknown lot number arthritis neck/shoulder/wrist (nsw) 12 hour product.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 trend identified related for the subclass adverse event safety request for investigation.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage, and investigation (citi) customizable search was performed: scope: date contacted: 11/04/2013 through 11/04/2016/manufacturing site: pfizer albany/complaint class: external cause investigation / complaint sub class: adverse event safety request for investigation.The citi customizable search returned a total of 15 complaints for arthritis neck/shoulder/wrist (nsw) 12hr products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.Adverse event safety request for investigation and adverse event negligible-minor.The data shows an increase of complaints received for the subclass in june 2016.All 3 complaints received in june were related to burns, blister and redness.The data did not show an increase over time (36 months).There is not a trend identified for the subclass adverse event safety request for investigation, adverse event safety request for investigation and adverse event negligible-minor for arthritis nsw 12hr products, refer to the attached trend chart for 04 november 2013 to 04 november 2016.There is no further action required.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 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 adverse event safety request for investigation.The manufacturing operations employ control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Additional information has been requested and will be provided as it becomes available.Follow-up (08nov2016): new information received from a contactable consumer includes: patient details, past product history, therapeutic measures taken, reaction data (additional events of erythema, dry skin and skin abrasion) and events outcome.Follow-up (14nov2016): new information received from a contactable consumer includes: added new events painful skin and skin peeled.Updated events outcome and stop date.Follow-up (04nov2016): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (19dec2019): this follow-up is being submitted to notify that an investigation of the device is ongoing.Follow up (20dec2019): 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 "skin peeled, skin abrasion, heat-induced like skin reaction at the site where heatwrap was administered/print of the adhesive strips on the skin of the neck" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events red, rough skin/red, rough and painful skin were assessed as non-serious.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events of "skin peeled, skin abrasion, heat-induced like skin reaction at the site where heatwrap was administered/print of the adhesive strips on the skin of the neck" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events red, rough skin/red, rough and painful skin were assessed as non-serious.The events are medically assessed as associated with the use of the device.

Event Description

Manufacturer Narrative

This investigation was conducted for an unknown lot number arthritis neck/shoulder/wrist (nsw) 12 hour product.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 trend identified related for the subclass adverse event safety request for investigation.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage, and investigation (citi) customizable search was performed: scope: date contacted: (b)(6)2013 through (b)(6)2016/manufacturing site: pfizer albany/complaint class: external cause investigation / complaint sub class: adverse event safety request for investigation.The citi customizable search returned a total of 15 complaints for arthritis neck/shoulder/wrist (nsw) 12hr products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.Adverse event safety request for investigation and adverse event negligible-minor.The data shows an increase of complaints received for the subclass in june 2016.All 3 complaints received in june were related to burns, blister and redness.The data did not show an increase over time (36 months).There is not a trend identified for the subclass adverse event safety request for investigation, adverse event safety request for investigation and adverse event negligible-minor for arthritis nsw 12hr products, refer to the attached trend chart for 04 november 2013 to 04 november 2016.There is no further action required.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.

Event Description

Event verbatim [preferred term] skin peeled [skin exfoliation] , superficial skin abrasion [skin abrasion] , heat-induced like skin reaction [skin reaction] , heat-induced like skin reaction at the site where heatwrap was administered/ print of the adhesive strips on the skin of the neck [application site reaction] , red, rough skin/red, rough and painful skin [erythema] , red, rough skin/red, rough and painful skin [dry skin] , the skin was rough and painful/red, rough and painful skin [pain of skin] ,.Case narrative:this is a spontaneous report from a contactable consumer.A 39-year-old female patient started to use thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number not reported) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.On an unspecified date in (b)(6)2016, the patient reported she administered the thermacare heatwrap during day time and took it off before sleeping.On the following morning she recognized a heat-induced like skin reaction at the site where she had administered the heatwrap the day before.The patient stated her skin was red and rough and she developed a superficial skin abrasion.The patient further reported that she suffered from a print of the adhesive strips on the neck.The problem of the patient was definitely due to the print and not due to the fact that the thermacare was too hot.The skin was rough and painful and the patient could not use a scarf.Her pharmacist said to her that the print was very strong and looked like a heat - induced reaction.She got an ointment and this ointment worked very well and within 2 days all events disappeared.The skin was very rough and it was likely that the skin peeled but there was no blister there.The patient did not visit a doctor.The patient did not suffer from sensible skin, skin diseases or from diabetes.In the past she used thermacare heatwrap without any problems for a maximum time period of five hours, as she did this time.She never slept on thermacare heatwrap.Action taken with the suspect product was unknown.Therapeutic measures taken included an unspecified ointment.Clinical outcome of the events was resolved in (b)(6)2016.Additional information received from product quality complaint (pqc) group included investigation results.This investigation was conducted for an unknown lot number arthritis neck/shoulder/wrist (nsw) 12 hour product.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 trend identified related for the subclass adverse event safety request for investigation.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage, and investigation (citi) customizable search was performed: scope: date contacted: (b)(6)2013 through (b)(6)2016/manufacturing site: pfizer albany/complaint class: external cause investigation / complaint sub class: adverse event safety request for investigation.The citi customizable search returned a total of 15 complaints for arthritis neck/shoulder/wrist (nsw) 12hr products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.Adverse event safety request for investigation and adverse event negligible-minor.The data shows an increase of complaints received for the subclass in june 2016.All 3 complaints received in june were related to burns, blister and redness.The data did not show an increase over time (36 months).There is not a trend identified for the subclass adverse event safety request for investigation, adverse event safety request for investigation and adverse event negligible-minor for arthritis nsw 12hr products for 04 november 2013 to 04 november 2016.There is no further action required.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 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 adverse event safety request for investigation.The manufacturing operations employ control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Follow-up (08nov2016): new information received from a contactable consumer includes: patient details, past product history, therapeutic measures taken, reaction data (additional events of erythema, dry skin and skin abrasion) and events outcome.Follow-up (14nov2016): new information received from a contactable consumer includes: added new events painful skin and skin peeled.Updated events outcome and stop date.Follow-up (04nov2016): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (19dec2019): this follow-up is being submitted to notify that an investigation of the device is ongoing.Follow up (20dec2019): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up (19feb2020): this follow-up report is being submitted to upgrade this case to a final reportable mdr., comment: based on the information provided, the events of "skin peeled, skin abrasion, heat-induced like skin reaction at the site where heatwrap was administered/print of the adhesive strips on the skin of the neck" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events red, rough skin/red, rough and painful skin were assessed as non-serious.The events are medically assessed as associated with the use of the device.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.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time.

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Brand Name

THERMACARE NECK, SHOULDER & WRIST

Type of Device

DISPOSABLE PACK, HOT

Manufacturer (Section D)

PFIZER CONSUMER HEALTH CARE

1231 wyandotte drive

albany GA 31705

MDR Report Key

9257387

MDR Text Key

167955555

Report Number

1066015-2019-00274

Device Sequence Number

Product Code

IMD

Combination Product (y/n)

PMA/PMN Number

K953442

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

consumer,foreign

Type of Report

Initial,Followup,Followup,Followup

Report Date

11/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Device Operator

Lay User/Patient

Was Device Available for Evaluation?

Initial Date Manufacturer Received

Not provided

Initial Date FDA Received

10/30/2019

Supplement Dates Manufacturer Received

Not provided
Not provided
Not provided

Supplement Dates FDA Received

12/23/2019
12/26/2019
03/02/2020

Is This a Reprocessed and Reused Single-Use Device?

Patient Sequence Number

Patient Outcome(s)

Required Intervention;

Patient Age

39 YR

MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE NECK, SHOULDER & WRIST; DISPOSABLE PACK, HOT

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