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

Lot Number DK2617

Device Problems Loss of or Failure to Bond (1068); Use of Device Problem (1670); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Event verbatim [preferred term], the black stuff came out [device leakage], pulled the adhesive more [device use error], narrative: this is a spontaneous report from a contactable consumer (patient).A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number dk2617, expiration date feb2023, via an unspecified route of administration from an unspecified date at unknown frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient got the thermacare neck wraps and the two ends didn't stick to the skin.The patient pulled the adhesive more and the black stuff came out.The patient shouldn't have pulled it that far.Action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available.

Event Description

Event verbatim [preferred term], the black stuff came out [device leakage], pulled the adhesive more [device use error], , narrative: this is a spontaneous report from a contactable consumer (patient).A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number dk2617, expiration date feb2023, via an unspecified route of administration from an unspecified date at unknown frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient got the thermacare neck wraps and the two ends didn't stick to the skin.The patient pulled the adhesive more and the black stuff came out.The patient shouldn't have pulled it that far.Action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events was unknown.Product investigation results are as follows: batch dk2617 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.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 processing inspections were performed and all inspection criteria were met.There was one attribute defect recorded on 06mar2020 for cell pack registration, adjustments were made by changing line speed from 320 to 200.This defect would not affect the adhesive missing on the wrap.The material records for nsw/mj skin contact adhesive laminate (sca); material number r000006147 were reviewed.There were three batches of sca used in the manufacturing of the batch, batches #, # and #.There were no raw material incident forms completed for these batches of sca material.Sca laminate passed all criteria for release for use in manufacturing.The batch has been reviewed from a manufacturing perspective.There were no investigations associated with this batch involving wrap adhesion defects.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the 13th complaint for the sub class adhesion/fastening defect received at the (name) site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result was 33.9.This result was below the upper control limit (ucl) of 189.5 complaints per sop-105746 complaint trending guideline, effective 24feb2020.On the basis of this evaluation, a trend does not exist for this batch.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).Sample is not available for evaluation by the site; complaint cannot be confirmed.After a review of the skin contact adhesive laminate (sca) material records for the batches of sca used in this batch the root cause of why the wraps would not adhere to the body for use is inconclusive since review of records does not provide evidence to support defective product.Sca laminate passed all criteria for release for use in manufacturing.Our 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.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks 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.Reasonably suggest device malfunction: yes.Severity of harm: s1.Site sample status: not received.Follow-up (08mar2021): follow-up attempts are completed.No further information is expected.Follow-up (03mar2021): new information received from product quality complaints includes: product investigation results.

Manufacturer Narrative

Batch dk2617 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.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 processing inspections were performed and all inspection criteria were met.There was one attribute defect recorded on 06mar2020 for cell pack registration, adjustments were made by changing line speed from 320 to 200.This defect would not affect the adhesive missing on the wrap.The material records for nsw/mj skin contact adhesive laminate (sca); material number r000006147 were reviewed.There were three batches of sca used in the manufacturing of the batch, batches #, # and #.There were no raw material incident forms completed for these batches of sca material.Sca laminate passed all criteria for release for use in manufacturing.The batch has been reviewed from a manufacturing perspective.There were no investigations associated with this batch involving wrap adhesion defects.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the 13th complaint for the sub class adhesion/fastening defect received at the (name) site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result was 33.9.This result was below the upper control limit (ucl) of 189.5 complaints per sop-105746 complaint trending guideline, effective 24feb2020.On the basis of this evaluation, a trend does not exist for this batch.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).Sample is not available for evaluation by the site; complaint cannot be confirmed.After a review of the skin contact adhesive laminate (sca) material records for the batches of sca used in this batch the root cause of why the wraps would not adhere to the body for use is inconclusive since review of records does not provide evidence to support defective product.Sca laminate passed all criteria for release for use in manufacturing.Our 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.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks 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.Reasonably suggest device malfunction: yes.Severity of harm: s1.Site sample status: not received.

Event Description

Event verbatim [preferred term].Pulled the adhesive more [device use error], the black stuff came out [device leakage], tried to get it to stick it got a hole in it [device breakage], it did not stick [device adhesion issue], , narrative: this is a spontaneous report from a contactable consumer (patient).A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number dk2617, expiration date feb2023) from an unspecified date at unknown frequency for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient got the thermacare neck wraps and the two ends didn't stick to the skin.It did not stick, and when the patient tried to get it to stick it got a hole in it on an unspecified date.The patient pulled the adhesive more and the black stuff came out.The patient shouldn't have pulled it that far.The patient threw the product away.Action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events was unknown.Product investigation results are as follows: batch dk2617 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.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 processing inspections were performed and all inspection criteria were met.There was one attribute defect recorded on 06mar2020 for cell pack registration, adjustments were made by changing line speed from 320 to 200.This defect would not affect the adhesive missing on the wrap.The material records for nsw/mj skin contact adhesive laminate (sca); material number r000006147 were reviewed.There were three batches of sca used in the manufacturing of the batch, batches #, # and #.There were no raw material incident forms completed for these batches of sca material.Sca laminate passed all criteria for release for use in manufacturing.The batch has been reviewed from a manufacturing perspective.There were no investigations associated with this batch involving wrap adhesion defects.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the 13th complaint for the sub class adhesion/fastening defect received at the (name) site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result was 33.9.This result was below the upper control limit (ucl) of 189.5 complaints per sop-105746 complaint trending guideline, effective 24feb2020.On the basis of this evaluation, a trend does not exist for this batch.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).Sample is not available for evaluation by the site; complaint cannot be confirmed.After a review of the skin contact adhesive laminate (sca) material records for the batches of sca used in this batch the root cause of why the wraps would not adhere to the body for use is inconclusive since review of records does not provide evidence to support defective product.Sca laminate passed all criteria for release for use in manufacturing.Our 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.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks 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.Reasonably suggest device malfunction: yes.Severity of harm: s1.Site sample status: not received.Follow-up (08mar2021): follow-up attempts are completed.No further information is expected.Follow-up (03mar2021): new information received from product quality complaints includes: product investigation results.Follow-up (25mar2021): this is a follow-up report combining information from duplicate reports 2021264962 and 2021218577.The current and all subsequent information will be reported under manufacturer report number 2021218577.New information from a contactable consumer includes: additional events ("it did not stick" and "when the patient tried to get it to stick it got a hole in it") and device availability (threw the product away).No follow-up attempts are needed.No further information is expected.

Manufacturer Narrative

Batch dk2617 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.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 processing inspections were performed and all inspection criteria were met.There was one attribute defect recorded on 06mar2020 for cell pack registration, adjustments were made by changing line speed from 320 to 200.This defect would not affect the adhesive missing on the wrap.The material records for nsw/mj skin contact adhesive laminate (sca); material number r000006147 were reviewed.There were three batches of sca used in the manufacturing of the batch, batches #, # and #.There were no raw material incident forms completed for these batches of sca material.Sca laminate passed all criteria for release for use in manufacturing.The batch has been reviewed from a manufacturing perspective.There were no investigations associated with this batch involving wrap adhesion defects.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the 13th complaint for the sub class adhesion/fastening defect received at the (name) site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result was 33.9.This result was below the upper control limit (ucl) of 189.5 complaints per sop-105746 complaint trending guideline, effective 24feb2020.On the basis of this evaluation, a trend does not exist for this batch.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).Sample is not available for evaluation by the site; complaint cannot be confirmed.After a review of the skin contact adhesive laminate (sca) material records for the batches of sca used in this batch the root cause of why the wraps would not adhere to the body for use is inconclusive since review of records does not provide evidence to support defective product.Sca laminate passed all criteria for release for use in manufacturing.Our 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.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks 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.Reasonably suggest device malfunction: yes.Severity of harm: s1.Site sample status: not received.

• 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: 11425809
• MDR Text Key: 242212078
• Report Number: 1066015-2021-00031
• 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,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2023
• Device Lot Number: DK2617
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1