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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE NECK, SHOULDER & WRIST; DISPOSABLE PACK, HOT
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PFIZER CONSUMER HEALTH CARE THERMACARE NECK, SHOULDER & WRIST; DISPOSABLE PACK, HOT Back to Search Results
Device Problems Loss of or Failure to Bond (1068); Leak/Splash (1354); Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
Sub-class: adhesion/fastening defect, severity of harm was s1.This investigation was conducted for an unknown lot number (nsw) 12hr.Conclusion: 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.Lot trend assessment and rationale: a lot trend was not performed as the lot number is unknown.Site sample status was not received.Sub-class: heat cells damaged/leaking, severity of harm was s3.This investigation was conducted for an unknown lot number arthritis neck/shoulder/wrist (nsw) 12hr product.Conclusion: 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 heat cells damaged/leaking.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.Lot trend assessment and rationale: a lot trend was not performed as the lot number is unknown.Site sample status was not received.
 
Event Description
Opened one up and the chemical was leaking in the package [device leakage].Narrative: this is a spontaneous report from a non-contactable consumer (patient) from a pfizer-sponsored program (b)(6) review & response program.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient reported that 2 of 4 were defective.Ran into a big problem when using the neck version.Opened one up and the chemical was leaking in the package.Got all over the patient's hands and was worried it was going to burn him/her.Washed and washed to make sure it wouldn't.And on another it would not stick to the patient's neck.Adhesive was useless.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the event was unknown.According to product complaint group on (b)(6) 2020, for sub-class: adhesion/fastening defect, severity of harm was s1.This investigation was conducted for an unknown lot number (nsw) 12hr.Conclusion: 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.Lot trend assessment and rationale: a lot trend was not performed as the lot number is unknown.Site sample status was not received.According to product complaint group on (b)(6) 2020, for sub-class: heat cells damaged/leaking, severity of harm was s3.This investigation was conducted for an unknown lot number arthritis neck/shoulder/wrist (nsw) 12hr product.Conclusion: 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 heat cells damaged/leaking.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.Lot trend assessment and rationale: a lot trend was not performed as the lot number is unknown.Site sample status was not received.Follow-up attempts completed.No further information expected.
 
Manufacturer Narrative
Sub-class: adhesion/fastening defect, severity of harm was s1.This investigation was conducted for an unknown lot number (nsw) 12hr.Conclusion: 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.Lot trend assessment and rationale: a lot trend was not performed as the lot number is unknown.Site sample status was not received.Sub-class: heat cells damaged/leaking, severity of harm was s3.This investigation was conducted for an unknown lot number arthritis neck/shoulder/wrist (nsw) 12hr product.Conclusion: 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 heat cells damaged/leaking.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.Lot trend assessment and rationale: a lot trend was not performed as the lot number is unknown.Site sample status was not received.
 
Event Description
Event verbatim [preferred term] got all over the patient's hands [accidental exposure to product], opened one up and the chemical was leaking in the package [device leakage], , narrative: this is a spontaneous report from a non-contactable consumer (patient) from a pfizer-sponsored program amazon vine review & response program.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient reported that 2 of 4 were defective.Ran into a big problem when using the neck version.Opened one up and the chemical was leaking in the package.Got all over the patient's hands and was worried it was going to burn him/her.Washed and washed to make sure it wouldn't.And on another it would not stick to the patient's neck.Adhesive was useless.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the event was unknown.According to product complaint group on (b)(6) 2020, for sub-class: adhesion/fastening defect, severity of harm was s1.This investigation was conducted for an unknown lot number (nsw) 12hr.Conclusion: 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.Lot trend assessment and rationale: a lot trend was not performed as the lot number is unknown.Site sample status was not received.According to product complaint group on (b)(6) 2020, for sub-class: heat cells damaged/leaking, severity of harm was s3.This investigation was conducted for an unknown lot number arthritis neck/shoulder/wrist (nsw) 12hr product.Conclusion: 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 heat cells damaged/leaking.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.Lot trend assessment and rationale: a lot trend was not performed as the lot number is unknown.Site sample status was not received.Follow-up attempts completed.No further information expected.Amendment: this follow-up report is being submitted to amend previously reported information: event term "opened one up and the chemical was leaking in the package" was upgraded to serious.Amendment: this follow-up report is being submitted to amend previously reported information: new event term "got all over the patient's hands" added and considered as serious.
 
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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 Key10455380
MDR Text Key225167022
Report Number1066015-2020-00157
Device Sequence Number1
Product Code IMD
Combination Product (y/n)N
PMA/PMN Number
K953442
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 06/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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