MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAP; DISPOSABLE PACK, HOT

Lot Number T73713

Device Problems Use of Device Problem (1670); Patient-Device Incompatibility (2682); Temperature Problem (3022); Excessive Heating (4030)

Patient Problems Pain (1994); Rash (2033)

Event Date 11/01/2019

Event Type  Injury  

Event Description

Rash developed on the affected body part, because the product heated up faster and unevenly [rash] , had not tolerated thermacare heatwrap as good as before [device intolerance] , rash developed on the affected body part, because the product heated up faster and unevenly [device issue] ,.Case narrative:this is a spontaneous report from a contactable consumer (patient).An approximately aged (b)(6) year-old female patient started to use thermacare heatwrap (thermacare heatwrap)(device lot number t73713, expiration date aug2020) for back pain 1x/day in (b)(6) 2019.Relevant medical history was not provided.No concomitant medications were taken.The patient stated she was wondering why she had not tolerated thermacare heatwrap as good as before.The intolerance was later described as: "a rash developed on the affected body part, because the product heated up faster and unevenly." the events' onset date was (b)(6) 2019.The patient did not receive any treatment for the events and no hospitalization was required.Thermacare was no longer used.The action taken in response to the events was permanently withdrawn.The clinical outcome of the events was recovered on an unspecified date.Additional information has been requested and will be provided as it becomes available.Follow-up (b)(6) 2020): new information received from the contactable consumer includes: patient information (age), suspect product information (indication, start date, frequency, action taken), concomitant medications (none), event information (onset date, outcome), new events (a rash developed on the affected body part, because the product heated up faster and unevenly), hospitalization information (none), and treatment information (none).This follow-up upgrades the case to a reportable mdr.No follow-up attempts needed.No further information expected., comment: based on the available information, the complaints of intolerance described as rash developed on the affected body part, because the product heated up faster and unevenly" 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 complaints cannot be ruled out.

Event Description

Event verbatim [preferred term] rash developed on the affected body part, because the product heated up faster and unevenly [rash], had not tolerated thermacare heatwrap as good as before [device intolerance], rash developed on the affected body part, because the product heated up faster and unevenly [device issue], , narrative: this is a spontaneous report from a contactable consumer (patient).An approximately aged 31-year-old female patient started to use thermacare heatwrap (thermacare heatwrap) (device lot number t73713, expiration date (b)(6)2020) for back pain 1x/day in (b)(6) 2019.Relevant medical history was not provided.No concomitant medications were taken.The patient stated she was wondering why she had not tolerated thermacare heatwrap as good as before.The intolerance was later described as: "a rash developed on the affected body part, because the product heated up faster and unevenly." the events' onset date was (b)(6)2019.The patient did not receive any treatment for the events and no hospitalization was required.Thermacare was no longer used.The action taken in response to the events was permanently withdrawn.The clinical outcome of the events was recovered on an unspecified date.Additional information has been requested and will be provided as it becomes available.Follow-up ((b)(6)2020): new information received from the contactable consumer includes: patient information (age), suspect product information (indication, start date, frequency, action taken), concomitant medications (none), event information (onset date, outcome), new events (a rash developed on the affected body part, because the product heated up faster and unevenly), hospitalization information (none), and treatment information (none).This followup upgrades the case to a reportable mdr.Follow-up ((b)(6)2020 and (b)(6)2020): this report has been downgraded to not reportable as no medical attention was required to prevent serious injury from the reported rash.No follow-up attempts needed.No further information expected.Comment: based on the available information, the complaints of intolerance described as rash developed on the affected body part, because the product heated up faster and unevenly" 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 complaints cannot be ruled out.

Manufacturer Narrative

Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch records, results all met product release criteria.Consumer reports the wrap caused "a rash developed on the affected body part." the cause of the consumer stating the wrap caused an "a rash developed on the affected body part" is inconclusive since review of records does not provide evidence to support defective product.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 at the time this investigation was written has expired.Expiry date was 2020-08.The product quality for the batch is not impacted by this complaint.A trend does not exist for this batch.Reasonably suggest device malfunction: no.Severity of harm: n/a.Site sample status: not received.

Event Description

Rash developed on the affected body part, because the product heated up faster and unevenly [rash], had not tolerated thermacare heatwrap as good as before [device intolerance], rash developed on the affected body part, because the product heated up faster and unevenly [device issue], narrative: this is a spontaneous report from a contactable consumer (patient).An approximately aged 31-year-old female patient started to use thermacare heatwrap (thermacare heatwrap) (device lot number t73713, expiration date aug2020) for back pain 1x/day in (b)(6) 2019.Relevant medical history was not provided.No concomitant medications were taken.The patient stated she was wondering why she had not tolerated thermacare heatwrap as good as before.The intolerance was later described as: "a rash developed on the affected body part, because the product heated up faster and unevenly." the events' onset date was (b)(6) 2019.The patient did not receive any treatment for the events and no hospitalization was required.Thermacare was no longer used.The action taken in response to the events was permanently withdrawn.The clinical outcome of the events was recovered on an unspecified date.Per the product quality group>:conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch records, results all met product release criteria.Consumer reports the wrap caused "a rash developed on the affected body part." the cause of the consumer stating the wrap caused an "a rash developed on the affected body part" is inconclusive since review of records does not provide evidence to support defective product.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 at the time this investigation was written has expired.Expiry date was 2020-08.The product quality for the batch is not impacted by this complaint.A trend does not exist for this batch.Reasonably suggest device malfunction: no.Severity of harm: n/a.Site sample status: not received.Follow-up (02apr2020): new information received from the contactable consumer includes: patient information (age), suspect product information (indication, start date, frequency, action taken), concomitant medications (none), event information (onset date, outcome), new events (a rash developed on the affected body part, because the product heated up faster and unevenly), hospitalization information (none), and treatment information (none).This follow-up upgrades the case to a reportable mdr.Follow-up (21may2020 and 26may2020): this report has been downgraded to not reportable as no medical attention was required to prevent serious injury from the reported rash.No follow-up attempts needed.No further information expected.Follow-up (30sep2020): new information received from product quality group includes investigation results.No follow-up attempts needed.No further information expected.

Manufacturer Narrative

Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch records, results all met product release criteria.Consumer reports the wrap caused "a rash developed on the affected body part." the cause of the consumer stating the wrap caused an "a rash developed on the affected body part" is inconclusive since review of records does not provide evidence to support defective product.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 at the time this investigation was written has expired.Expiry date was 2020-08.The product quality for the batch is not impacted by this complaint.A trend does not exist for this batch.Reasonably suggest device malfunction: no.Severity of harm: n/a.Site sample status: not received.

Event Description

Event verbatim [preferred term] rash developed on the affected body part, because the product heated up faster and unevenly [rash], had not tolerated thermacare heatwrap as good as before [device intolerance], rash developed on the affected body part, because the product heated up faster and unevenly [device issue], , narrative: this is a spontaneous report from a contactable consumer (patient).An approximately aged 31-year-old female patient started to use thermacare heatwrap (thermacare heatwrap) (device lot number t73713, expiration date aug2020) for back pain 1x/day in (b)(6) 2019.Relevant medical history was not provided.No concomitant medications were taken.The patient stated she was wondering why she had not tolerated thermacare heatwrap as good as before.The intolerance was later described as: "a rash developed on the affected body part, because the product heated up faster and unevenly." the events' onset date was (b)(6) 2019.The patient did not receive any treatment for the events and no hospitalization was required.Thermacare was no longer used.The action taken in response to the events was permanently withdrawn.The clinical outcome of the events was recovered on an unspecified date.Per the product quality group:conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch records, results all met product release criteria.Consumer reports the wrap caused "a rash developed on the affected body part." the cause of the consumer stating the wrap caused an "a rash developed on the affected body part" is inconclusive since review of records does not provide evidence to support defective product.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 at the time this investigation was written has expired.Expiry date was 2020-08.The product quality for the batch is not impacted by this complaint.A trend does not exist for this batch.Reasonably suggest device malfunction: no.Severity of harm: n/a.Site sample status: not received.Follow-up (02apr2020): new information received from the contactable consumer includes: patient information (age), suspect product information (indication, start date, frequency, action taken), concomitant medications (none), event information (onset date, outcome), new events (a rash developed on the affected body part, because the product heated up faster and unevenly), hospitalization information (none), and treatment information (none).This follow-up upgrades the case to a reportable mdr.Follow-up (21may2020 and 26may2020): this report has been downgraded to not reportable as no medical attention was required to prevent serious injury from the reported rash.Follow-up (30sep2020): new information received from product quality group includes investigation results.Amendment: this follow-up report is being submitted to notify us food and drug administration (fda) that mfr report number 1066015-2020-00098 and mfr report number 1066015-2020-00123 are duplicate.All subsequent follow-up information will be reported under mfr report number 1066015-2020-00098.Mfr report number 1066015-2020-00123 is to be considered as deleted.No follow-up attempts needed.No further information expected.

• Brand Name: THERMACARE HEATWRAP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 9953362
• MDR Text Key: 189453395
• Report Number: 1066015-2020-00098
• 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,foreign
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2020
• Device Lot Number: T73713
• Date Manufacturer Received: 05/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR