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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Erythema (1840); Itching Sensation (1943); Increased Sensitivity (2065); Burning Sensation (2146); Fluid Discharge (2686); Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Manufacturer Narrative

Company clinical evaluation comment: based on the information provided, the events burn blister, wound secretion, pruritus, erythema, and hyperesthesia as described in this case represent a 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.

Event Description

Wound weeping with small burn blister [burns second degree], wound weeping with small burn blister [wound secretion], unpleasant skin sensation with itching/burning, skin redness similar to a sunburn [pruritus], unpleasant skin sensation with itching/burning, skin redness similar to a sunburn [erythema], neck area became more sensitive for warmth [hyperaesthesia].Case description: this is a spontaneous report from a non-clinical-study program brand websites for division consumer healthcare (b)(4) from a contactable consumer.A female patient of an unspecified age and ethnicity started to use thermacare heatwrap (thermacare heatwrap), on an unspecified date for neck tightness.The pt medical history and concomitant medications were not reported.Thermacare heatwrap was tolerated well in the past.On an unknown date, for the second time within a few weeks.Approximately 3 hours after application of the thermacare heatwrap, the patient experienced an unpleasant skin sensation with itching/burning.After immediate removal of the heat wrap skin redness similar to a sunburn as well as a weeping wound with a small burn blister were detected.The neck area became more sensitive for warmth now and therefore the relief of the tightness is very impaired.The outcome of the events was unknown.The action taken in response to the events for thermacare heatwrap was unknown.Additional information has been requested and will be provided as it becomes available.

Event Description

Event verbatim [preferred term], wound weeping with small burn blister [burns second degree], wound weeping with small burn blister [wound secretion], neck area became more sensitive for warmth [hyperaesthesia], narrative: this is a spontaneous report from a pfizer-sponsored-program brand websites for division consumer healthcare german from a contactable consumer.A female patient of an unspecified age started to use thermacare heatwrap (thermacare heatwrap), on an unspecified date for neck tightness.The patient medical history and concomitant medications were not reported.Thermacare heatwrap was tolerated well in the past.On an unknown date, for the second time within a few weeks, approximately 3 hours after application of the thermacare heatwrap, the patient experienced an unpleasant skin sensation with itching/burning.After immediate removal of the heat wrap skin redness similar to a sunburn as well as a weeping wound with a small burn blister were detected.The neck area became more sensitive for warmth now and therefore the relief of the tightness was very impaired.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events was unknown.According to product quality group: 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, 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 has not been received.Follow-up (prd/srd 25jun2015): follow-up attempts completed.No further information expected.Follow up (05jun2020): new information received from product quality complaint group includes investigation results.Follow-up attempts are completed.No further information is expected.

Manufacturer Narrative

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, 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 has not been received.

• 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: 4769000
• MDR Text Key: 23124355
• Report Number: 1066015-2015-00045
• 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,Consumer,consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 05/05/2015

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: 05/05/2015
• Initial Date FDA Received: 05/12/2015
• Supplement Dates Manufacturer Received: 05/05/2015
• Supplement Dates FDA Received: 06/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention