MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE LOWER BACK & HIP; DISPOSABLE PACK, HOT

Lot Number W24913, W38032

Device Problems Nonstandard Device (1420); Overheating of Device (1437); Product Quality Problem (1506); Excessive Heating (4030)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

When i used one i had trouble with it being too hot in certain places/consumer is diabetic [device use issue].Case narrative: this is a spontaneous report from a contactable consumer (patient).A female patient of an unspecified age started to use thermacare heatwrap (thermacare lower back & hip) (device lot number w38032, expiration date may2021, device lot number w24913) from an unspecified date since more than 60 days before (b)(6) 2019 at an unknown frequency for an unspecified indication.Medical history included ongoing diabetic.The patient's concomitant medications were not reported.The patient was calling about the thermacare recall.The patient stated when she used one she had trouble with it being too hot in certain places since more than 60 days before (b)(6) 2019.The patient stated that she had an unopened box of thermacare heatwrap and she understood it was from the bad batch that had been recalled and wanting reimbursement for the unopened box that she had bought.The patient clarified that second lot w24913 provided was for product that had not yet been opened.She knew she had to be really careful with the product before.Action taken in response to the event for thermacare heatwrap was permanently withdrawn on more than 60 days before (b)(6) 2019.The event outcome was unknown.According to the product quality complaint group: reasonably suggest device malfunction: yes; severity of harm: s3; complaint class: product use attributes; complaint sub-class: wrap/patch/pad too hot; related to potential ae: yes; status: investigation in progress.Follow-up ((b)(6) 2019): new information received from a contactable consumer included: event details.Follow-up (03jul2019): new information received from the product quality complaint group includes device information, malfunction and severity of harm assessment and case upgraded to be serious, reportable mdr.No follow-up attempts are possible.No further information is expected.

Event Description

When i used one i had trouble with it being too hot in certain places/consumer is diabetic [device use issue].Case description: this is a spontaneous report from a contactable consumer (patient).A female patient of an unspecified age started to use thermacare heatwrap (thermacare lower back & hip) (device lot number w38032, expiration date 31may2021, device lot number w24913, expiration date 31mar2021) from an unspecified date since more than 60 days before (b)(6) 2019 at an unknown frequency for an unspecified indication.Medical history included ongoing diabetic.The patient's concomitant medications were not reported.The patient was calling about the thermacare recall.The patient stated when she used one she had trouble with it being too hot in certain places since more than 60 days before (b)(6) 2019.The patient stated that she had an unopened box of thermacare heatwrap and she understood it was from the bad batch that had been recalled and wanting reimbursement for the unopened box that she had bought.The patient clarified that second lot w24913 provided was for product that had not yet been opened.She knew she had to be really careful with the product before.Action taken in response to the event for thermacare heatwrap was permanently withdrawn on more than 60 days before (b)(6) 2019.The event outcome was unknown.Follow-up (15may2019): new information received from a contactable consumer included: event details.Follow-up (03jul2019): new information received from the product quality complaint group includes device information, malfunction and severity of harm assessment and case upgraded to be serious, reportable mdr.No follow-up attempts are possible.No further information is expected.Follow up (06aug2019): this is a follow-up report received from the product quality complaint group includes expiration date, malfunction and severity of harm assessment removed and case downgraded to be non-serious and not reportable mdr.Follow-up attempts are completed.No further information is expected.

Event Description

Event verbatim [preferred term] when i used one i had trouble with it being too hot in certain places/consumer is diabetic [device use issue], narrative: this is a spontaneous report from a contactable consumer (patient).A female patient of an unspecified age started to use thermacare heatwrap (thermacare lower back & hip) (device lot number w38032, expiration date may2021; device lot number w24913, expiration date mar2021) from an unspecified date since more than 60 days before (b)(6) 2019 at an unknown frequency for an unspecified indication.Medical history included ongoing diabetic.The patient's concomitant medications were not reported.The patient was calling about the thermacare recall.The patient stated when she used one she had trouble with it being too hot in certain places since more than 60 days before (b)(6) 2019.The patient stated that she had an unopened box of thermacare heatwrap and she understood it was from the bad batch that had been recalled and wanting reimbursement for the unopened box that she had bought.The patient clarified that second lot w24913 provided was for product that had not yet been opened.She knew she had to be really careful with the product before.Action taken in response to the event for thermacare heatwrap was permanently withdrawn on more than 60 days before (b)(6) 2019.The event outcome was unknown.According to product quality complaint group: summary of investigation: batch w24913 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Site conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the third complaint for the sub class adverse event safety request for investigation received at the site requiring an evaluation for this batch.The previous complaints were not confirmed to have a manufacturing related root cause for the complaint.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Exped trend actions taken: based on this citi customizable search for the subclass of adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor for lbh products the data did not show an increase over time (24 months).Summary of investigation: batch w38032 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap temperatures.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Site conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports," when i used one i had trouble with it being too hot in certain places." the cause of the wrap getting to hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event safety request for investigation received at the site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Sample have not been received by the site.The severity of harm was s3.Dchu conclusion: based on the complaint narrative, the patient experienced the heat wrap being too hot in certain places during use.There was no burn injury reported.Review of complaint description concludes there is no device malfunction.Follow-up ((b)(6) 2019): new information received from a contactable consumer included: event details.Follow-up (03jul2019): new information received from the product quality complaint group includes device information, malfunction and severity of harm assessment and case upgraded to be serious, reportable mdr.No follow-up attempts are possible.No further information is expected.Follow up (06aug2019): this is a follow-up report received from the product quality complaint group includes expiration date, malfunction and severity of harm assessment removed and case downgraded to be non-serious and not reportable mdr.Follow-up attempts are completed.No further information is expected.Follow up (28aug2019, 23sep2019, 04sep2019 and 16oct2019): new information received from the product quality complaint group includes site conclusion, dchu conclusion and severity rating.Amendment: this follow-up report is being submitted to notify us food and drug administration (fda) that mfr report number 1066015-2019-00210 and mfr report number 1066015-2019-00218 are duplicate.All subsequent follow-up information will be reported under mfr report number 1066015-2019-00210.Mfr report number 1066015-2019-00218 is to be considered as deleted.

Manufacturer Narrative

Summary of investigation: batch w24913 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Site conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the third complaint for the sub class adverse event safety request for investigation received at the site requiring an evaluation for this batch.The previous complaints were not confirmed to have a manufacturing related root cause for the complaint.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Exped trend actions taken: based on this citi customizable search for the subclass of adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor for lbh products the data did not show an increase over time (24 months).Summary of investigation: batch w38032 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap temperatures.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Site conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports," when i used one i had trouble with it being too hot in certain places." the cause of the wrap getting to hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event safety request for investigation received at the site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.

• Brand Name: THERMACARE LOWER BACK & HIP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 8857681
• MDR Text Key: 153842407
• Report Number: 1066015-2019-00210
• 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: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2021
• Device Lot Number: W24913, W38032
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention