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

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 11/26/2015

Event Type  Injury  

Event Description

After creaming a burning occurred, which then led to the formation of blisters [burns second degree].Case description: this is a spontaneous report from a contactable pharmacist via pfizer consumer healthcare.A female patient of approximately 30-40 years started to use thermacare heatwrap (thermacare fuer flexible anwendung), from an unspecified date to an unspecified date at 1 df, daily for an unspecified indication.The patient medical history was not reported.The patient's concomitant medications were not reported.The patient experienced a burn blister on (b)(6) 2015.It was reported the patient removed the thermacare flex heatwrap before showering, then she creamed.After creaming a burning occurred, which then led to the formation of blisters.The action taken in response to the event for thermacare heatwrap was permanently withdrawn on an unspecified date, and the reaction did not disappear after withdrawal.The outcome for the event was reported to be resolving (now has been declined only slowly).Causality was reported as related.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the event of burn blister as described in this case is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the event of burn blister as described in this case is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.

Manufacturer Narrative

This investigation was conducted for an unknown lot number flexible use product.The root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The 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.Site sample status was not received.

Event Description

Event verbatim [preferred term].After creaming a burning occurred, which then led to the formation of blisters/burn blister [burns second degree].Narrative: this is a spontaneous report from a contactable pharmacist via pfizer consumer healthcare reporting for a patient.A 35-year-old female patient (reported as "approximately 30-40 years") started to use thermacare heatwrap (thermacare fuer flexible anwendung), from an unspecified date to an unspecified date at 1 wrap, daily for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient experienced a burn blister on (b)(6) 2015.It was reported the patient removed the thermacare flex heatwrap before showering, then she creamed.After creaming a burning occurred, which then led to the formation of blisters.The action taken in response to the event for thermacare heatwrap was permanently withdrawn on an unspecified date, and the reaction did not disappear after withdrawal.The outcome of the event was resolving (now had been declined only slowly).Causality was reported as related.According to the product quality complaint group: this investigation was conducted for an unknown lot number flexible use product.The root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The 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.Site sample status was not received.Follow-up (28dec2015): follow-up attempts completed.No further information expected.Follow-up (06aug2020): new information received from the product quality complaint group included investigational results.Follow-up attempts are completed.No further information is expected.

• 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: 5306769
• MDR Text Key: 33825138
• Report Number: 1066015-2015-00151
• 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
• Report Date: 11/30/2015

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
• Initial Date Manufacturer Received: 11/30/2015
• Initial Date FDA Received: 12/17/2015
• Supplement Dates Manufacturer Received: 11/30/2015
• Supplement Dates FDA Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR