MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE FUER FLEXIBLE ANWENDUNG; DISPOSABLE PACK, HOT

Lot Number T73713

Device Problems Overheating of Device (1437); Excessive Heating (4030)

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

Event Type  malfunction  

Event Description

The heat wraps got too hot [device issue].Case narrative: this is a spontaneous report from a contactable pharmacist.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare fuer flexible anwendung), device lot number: t73713, expiration date: aug-2020, from an unspecified date for an unspecified indication.The patient medical history and concomitant medications were not reported.It was reported the heat wraps got too hot on an unspecified date.The action taken in response to the event for the product was unknown.The event outcome was unknown.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: the event "got too hot " (device issue) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device., comment: the event "got too hot " (device issue) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device.

Manufacturer Narrative

Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).Consumer reports "the heat wraps got too hot." the cause of the consumer statement "the heat wraps got too hot.¿ is inconclusive.The review of records does not provide evidence to support the defective product.The product effect may vary with each individual.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.Reasonably suggest device malfunction: no.Severity of harm: n/a.Site sample status was not received.

Event Description

Event verbatim [preferred term] the heat wraps got too hot [device issue], , narrative: this is a spontaneous report from a contactable pharmacist.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare fuer flexible anwendung), device lot number: t73713, expiration date: aug2020, from an unspecified date for an unspecified indication.The patient medical history and concomitant medications were not reported.It was reported the heat wraps got too hot on an unspecified date.The action taken in response to the event for the product was unknown.The event outcome was unknown.Product investigation results are as follows: conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).Consumer reports "the heat wraps got too hot." the cause of the consumer statement "the heat wraps got too hot." is inconclusive.The review of records does not provide evidence to support the defective product.The product effect may vary with each individual.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.Reasonably suggest device malfunction: no.Severity of harm: n/a.Site sample status was not received.Follow-up attempts are completed.No further information is expected.Follow-up (b)(6) 2020: new information received from citi includes: investigation results.Follow-up attempts are completed.No further information is expected., comment: the event "got too hot " (device issue) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device.

Manufacturer Narrative

Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).Consumer reports "the heat wraps got too hot." the cause of the consumer statement "the heat wraps got too hot." is inconclusive.The review of records does not provide evidence to support the defective product.The product effect may vary with each individual.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 second complaint for the subclass wrap/patch/pad too hot received at the albany site requiring an evaluation for this batch.The previous complaint did not confirm to have a manufacturing root cause related to the subclass.The complaint was evaluated to identify any potential trend.Per sop-105746, complaint trending guideline, effective 24-feb-2020, a visual evaluation was performed to identify a potential trend for the lot and subclass.A trend was not identified.Refer to trending chart attachment wrap/patch/pad too hot t73713.On this basis, a trend does not exist for this batch.Lot trend actions taken: a trend does not exist for this batch.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this customizable citi search, a trend does not exist for the subclass wrap/patch/pad too hot for flexible use xl products.Refer to the 36-month trend chart attachment refer to attachment wrap/patch/pad too hot flexible use xl 04-06-2017 to 04-06-2020.Exped trend actions taken: there was deviation from sop-105746, complaint trending guidelines, effective 24-feb-2020 in which the expedite trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in (b)(4), action item (b)(4).

Event Description

Event verbatim [preferred term], the heat wraps got too hot [device issue], , narrative: this is a spontaneous report from a contactable pharmacist.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare fuer flexible anwendung), device lot number: t73713, expiration date: aug2020, from an unspecified date for an unspecified indication.The patient medical history and concomitant medications were not reported.It was reported the heat wraps got too hot on an unspecified date.The action taken in response to the event for the product was unknown.The event outcome was unknown.Product investigation results are as follows: conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).Consumer reports "the heat wraps got too hot." the cause of the consumer statement "the heat wraps got too hot." is inconclusive.The review of records does not provide evidence to support the defective product.The product effect may vary with each individual.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 second complaint for the subclass wrap/patch/pad too hot received at the albany site requiring an evaluation for this batch.The previous complaint did not confirm to have a manufacturing root cause related to the subclass.The complaint was evaluated to identify any potential trend.Per sop-105746, complaint trending guideline, effective 24-feb-2020, a visual evaluation was performed to identify a potential trend for the lot and subclass.A trend was not identified.Refer to trending chart attachment wrap/patch/pad too hot t73713.On this basis, a trend does not exist for this batch.Lot trend actions taken: a trend does not exist for this batch.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this customizable citi search, a trend does not exist for the subclass wrap/patch/pad too hot for flexible use xl products.Refer to the 36-month trend chart attachment refer to attachment wrap/patch/pad too hot flexible use xl 04-06-2017 to 04-06-2020.Exped trend actions taken: there was deviation from sop-105746, complaint trending guidelines, effective 24-feb-2020 in which the expedite trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in (b)(4), action item (b)(4).Site sample status was not received.Follow-up attempts are completed.No further information is expected.Follow-up (26may2020): new information received from citi includes: investigation results.Follow-up attempts are completed.No further information is expected.Follow-up (16oct2020): new information received from product quality complaint group included: updated trend information.Follow-up attempts are completed.No further information is expected., comment: the event "got too hot " (device issue) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device.

• Brand Name: THERMACARE FUER FLEXIBLE ANWENDUNG
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 9959275
• MDR Text Key: 188250429
• Report Number: 1066015-2020-00101
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2020
• Device Lot Number: T73713
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/14/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/03/2020; 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1