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

Lot Number T73713

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Urticaria (2278)

Event Type  Injury  

Event Description

Pustules [pustule], hives [urticaria.Case narrative: this is a spontaneous report from a contactable pharmacist.A male patient of an unknown age started to use thermacare heatwrap (thermacare fuer flexible anwendung) (device lot number t73713, expiration date aug2020) on an unknown date for an unknown indication.Relevant medical history included diabetes mellitus.Concomitant medications were not provided.The pharmacist reported that the patient developed pustules (upon call-back of pharmacist later referred to as "hives") after using the product for larger body areas.The action taken with thermacare heatwrap in response to the events and the clinical outcome of the events were unknown at the time of the report.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the events pustule and urticaria as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.Comment: based on the information provided, the events pustule and urticaria as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.

Manufacturer Narrative

Severity of harm was s3 and the site sample status was not received.There was no reasonable suggestion of device malfunction.Batch t73713 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve sample, and trending were evaluated.No quality issues were identified.The root cause category is non assignable (complaint not confirmed as a quality defect).Consumer reports "patient developed pustules, upon call-back of pharmacist later referred to as hives." the cause of the consumer developing "pustules, upon call-back of pharmacist later referred to as hives" 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.

Event Description

Event verbatim [preferred term] hives/ wheals located on the back [urticaria].Case narrative:this is a spontaneous report from a contactable pharmacist.A male patient of an unknown age started to use thermacare heatwrap (thermacare fuer flexible anwendung) (device lot number t73713, expiration date aug2020) on an unknown date for an unknown indication.Relevant medical history included diabetes mellitus.Concomitant medications were not provided.The pharmacist reported that the patient developed pustules (upon call-back of pharmacist later referred to as "hives") after using the product for larger body areas.The same pharmacist later clarified, "we do not know about pustules, only about wheals located on the back." the event was reported as a new event and the patient consulted a physician as a result.It was unknown if the patient took (topical) medication at time of use, underwent surgical intervention, or experienced lasting damage (i.E.Scars).The action taken with thermacare heatwrap in response to the events and the clinical outcome of the events were unknown at the time of the report.According to product quality complaints: severity of harm was s3 and the site sample status was not received.There was no reasonable suggestion of device malfunction.Batch t73713 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve sample, and trending were evaluated.No quality issues were identified.The root cause category is non assignable (complaint not confirmed as a quality defect).Consumer reports "patient developed pustules, upon call-back of pharmacist later referred to as hives." the cause of the consumer developing "pustules, upon call-back of pharmacist later referred to as hives" 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.Follow-up (05mar2020, 10mar2020, and 12mar2020): new information received from product quality complaints and from the same contactable pharmacist includes: investigation results; event details ("we do not know about pustules, only about wheals located on the back"), updated events (removed "pustules" and updated event verbatim), and treatment details (unknown)., comment: based on the information provided, the event urticaria as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.

Event Description

Hives / wheals located on the back [urticaria].Narrative: this is a spontaneous report from a contactable pharmacist.A male patient of an unknown age started to use thermacare heatwrap (thermacare fuer flexible anwendung) (device lot number: t73713, expiration date: aug2020) on an unknown date for an unknown indication.Relevant medical history included ongoing diabetes mellitus.Concomitant medications were not provided.The pharmacist reported that the patient developed pustules (upon call-back of pharmacist later referred to as "hives") after using the product for larger body areas.The same pharmacist later clarified, "we do not know about pustules, only about wheals located on the back." the event was reported as a new event and the patient consulted a physician as a result.It was unknown if the patient took (topical) medication at time of use, underwent surgical intervention, or experienced lasting damage (i.E.Scars).The action taken with thermacare heatwrap in response to the events and the clinical outcome of the events were unknown at the time of the report.According to product quality complaints: severity of harm was s3 and the site sample status was not received.There was no reasonable suggestion of device malfunction.Batch: t73713 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve sample, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).Consumer reports "patient developed pustules, upon call-back of pharmacist later referred to as hives." the cause of the consumer developing "pustules, upon call-back of pharmacist later referred to as hives" 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 adverse event / serious / unknown received at the albany site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend.Per (b)(4), 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.On this basis, 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 adverse event / serious / unknown.Exped trend actions taken: there was deviation from (b)(4), 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.Follow-up (05mar2020, 10mar2020, and 12mar2020): new information received from product quality complaints and from the same contactable pharmacist includes: investigation results; event details ("we do not know about pustules, only about wheals located on the back"), updated events (removed "pustules" and updated event verbatim), and treatment details (unknown).Follow-up (16oct2020): new information received from product quality complaints includes updated expedite trending assessment., comment: based on the information provided, the event urticaria as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.There is not a complaint trend for any class(es) associated to the suggested key product complaints database terms.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.

Manufacturer Narrative

Batch: t73713 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve sample, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).Consumer reports "patient developed pustules, upon call-back of pharmacist later referred to as hives." the cause of the consumer developing "pustules, upon call-back of pharmacist later referred to as hives" 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 adverse event / serious / unknown received at the albany site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend.Per (b)(4), 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.On this basis, 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 adverse event / serious / unknown.Exped trend actions taken: there was deviation from (b)(4), 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.

• 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: 9808296
• MDR Text Key: 190339237
• Report Number: 1066015-2020-00058
• 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: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 03/09/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/01/2020; 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention