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

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

Patient Problems Abrasion (1689); Pain (1994); Tissue Damage (2104)

Event Date 03/12/2019

Event Type  Injury  

Manufacturer Narrative

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 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.Notification to safety is not required.This event has a severity of s2, minor - injury which may require medical treatment, but unlikely to cause hospitalization inconvenient, annoying but no harm.No further investigation or action required.

Event Description

When removed from it at home after work part it peeled of part by skin [skin abrasion] , i' m hurting from taking off the wrap [pain].Case narrative: this is a spontaneous report from a contactable consumer.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), from an unspecified date, for an unspecified indication.Medical history and concomitant medications were not reported.The patient stated "i had it on from 9am to 5pm today ((b)(6) 2019) at work.When removed from it at home after work part it peeled off part by skin, i'm not allergic to adhesive never been.Beside that my neck still stiff now i'm hurting from taking off the wrap.Wasn't expecting this use the many times in the past never happened to me before".The action taken with thermacare heatwrap and the outcome of the events was unknown.According to product quality complaint group: 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 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.Notification to safety is not required.This event has a severity of s2, minor - injury which may require medical treatment, but unlikely to cause hospitalization inconvenient, annoying but no harm.No further investigation or action required.Follow-up (01jun2019): follow-up attempts are completed.No further information is expected.Follow up (31may2019): new information received from a pfizer sponsored program via product quality complaint group included: investigation results.Follow-up (12mar2019): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment: based on the information provided, the events of "when removed from it at home after work part it peeled of part by skin, i'm hurting from taking off the wrap" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the events cannot be ruled out.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 further investigations or actions is suggested at this time., comment: based on the information provided, the events of "when removed from it at home after work part it peeled of part by skin, i'm hurting from taking off the wrap" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the events cannot be ruled out.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 further investigations or actions is suggested at this time.

Event Description

Event verbatim [preferred term] when removed from it at home after work part it peeled of part by skin [skin abrasion] , i' m hurting from taking off the wrap [pain].Case narrative:this is a spontaneous report from a contactable consumer.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), from an unspecified date, for an unspecified indication.Medical history and concomitant medications were not reported.The patient stated "i had it on from 9am to 5pm today ((b)(6) 2019) at work.When removed from it at home after work part it peeled off part by skin, i'm not allergic to adhesive never been.Beside that my neck still stiff now i'm hurting from taking off the wrap.Wasn't expecting this use the many times in the past never happened to me before." the action taken with thermacare heatwrap and the outcome of the events was unknown.According to product quality complaint group: 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 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.Notification to safety is not required.This event has a severity of s2, minor - injury which may require medical treatment, but unlikely to cause hospitalization inconvenient, annoying but no harm.No further investigation or action required.According to product quality complaint group, the severity of harm was assessed as s3.Additional information has been requested and will be provided as it becomes available.Follow-up (01jun2019): follow-up attempts are completed.No further information is expected.Follow-up (31may2019): new information received from a pfizer sponsored program via product quality complaint group included: investigation results.Follow-up (12mar2019): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (04nov2019): new information received from product quality complaint group included: the severity of harm was assessed as s3.Company clinical evaluation comment: based on the information provided, the events of "when removed from it at home after work part it peeled of part by skin, i'm hurting from taking off the wrap" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the events cannot be ruled out.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.The company is conducting further review on this investigation and additional follow-up will be reported when the evaluation is completed.Comment: based on the information provided, the events of "when removed from it at home after work part it peeled of part by skin, i'm hurting from taking off the wrap" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the events cannot be ruled out.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.The company is conducting further review on this investigation and additional follow-up will be reported when the evaluation is completed.

Manufacturer Narrative

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 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.Notification to safety is not required.This event has a severity of s2, minor - injury which may require medical treatment, but unlikely to cause hospitalization inconvenient, annoying but no harm.No further investigation or action required.

• 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: 9261086
• MDR Text Key: 173251674
• Report Number: 1066015-2019-00433
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/12/2019

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?: No
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention