MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAPS - FLEXIBLE USE; DISPOSABLE PACK, HOT

Lot Number T48946

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Swelling (2091); Partial thickness (Second Degree) Burn (2694)

Event Date 02/01/2019

Event Type  Injury  

Event Description

Event verbatim [preferred term] burns and blister [burns second degree], got worse inflammation [application site inflammation].Case narrative:this is a spontaneous report from a contactable consumer.A (b)(6) year-old male patient started to use thermacare heatwrap (thermacare heatwraps - flexible use) (device lot number t48946, serial number (b)(4)) on his back in (b)(6) 2019 for an unspecified indication.The patient medical history and concomitant medications were not reported.Patient has known the product for a long time and he used the product after instructions (<8h).Patient used "thermacare warm pads, the latest product, new tried out on his back." the patient experienced "burns and blisters" in (b)(6) 2019 (1 week ago).The patient went to the doctor, and he got a disinfectant.It was reported that he got worse inflammation on an unknown date.Therapeutic measures were taken as a result of burns and blister.The outcome of the events was not recovered.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the events of "burns and blisters" and "inflammation" as described are considered serious bodily injury 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 of "burns and blisters" and "inflammation" as described are considered serious bodily injury 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

The root cause category is non assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.The adverse event was reported because wrap caused "burning with blisters." the cause of the burn is inconclusive since review of records does not provide evidence to support 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] burns and blister [burns second degree] , got worse inflammation [application site inflammation] ,.Case narrative:this is a spontaneous report from a contactable consumer.A 73-year-old male patient started to use thermacare heatwrap (thermacare heatwraps - flexible use) (device lot number t48946, serial number (b)(6), expiry date: aug2020) on his back in (b)(6) 2019 for an unspecified indication.The patient medical history and concomitant medications were not reported.Patient has known the product for a long time and he used the product after instructions (<8h).Patient used "thermacare warm pads, the latest product, new tried out on his back." the patient experienced "burns and blisters" in (b)(6) 2019 (1 week ago).The patient went to the doctor, and he got a disinfectant.It was reported that he got worse inflammation on an unknown date in (b)(6) 2019.Therapeutic measures were taken as a result of burns and blister.The action taken for thermacare heatwraps - flexible use was unknown.The outcome of the events was not recovered.According to product quality complaint, the root cause category is non assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.The adverse event was reported because wrap caused "burning with blisters." the cause of the burn is inconclusive since review of records does not provide evidence to support 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 (02apr2019): new information received from product quality complaint group includes investigation results and expiry date for suspect product., comment: based on the information provided, the events of "burns and blisters" and "inflammation" as described are considered serious bodily injury 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.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.The product quality for the batch is not impacted by this complaint.No device malfunction has been identified.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time.

• Brand Name: THERMACARE HEATWRAPS - FLEXIBLE USE
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 8378699
• MDR Text Key: 137453396
• Report Number: 1066015-2019-00049
• 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
• Report Date: 02/22/2019

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: T48946
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR