MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE LOWER BACK & HIP; DISPOSABLE PACK, HOT

Lot Number CW8013

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

Patient Problem Burn, Thermal (2530)

Event Type  Injury  

Event Description

Event verbatim [preferred term], burn blisters [burns second degree].Narrative: this is a spontaneous report from a contactable consumer (parent of patient) via angelini pharma.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip), device lot number cw8013, via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication.The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient got burn blisters after using a patch.The action taken in response to the event(s) for thermacare heatwrap and the clinical outcome of the event were unknown.Additional information has been requested and will be provided as it becomes available.

Event Description

Event verbatim [preferred term] burn blisters [burns second degree], , narrative: this is a spontaneous report from a contactable consumer (parent of patient) via angelini pharma.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip), device lot number cw8013, via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication.The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient got burn blisters after using a patch.The action taken in response to the event(s) for thermacare heatwrap and the clinical outcome of the event were unknown.On 25feb2021, the product quality complaint group provided the following investigation results that yielded no product quality issues.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "burn blisters after using thermacare".The cause of the consumer stating the wrap caused "burn blisters after using thermacare" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.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.Additional information has been requested and will be provided as it becomes available.Follow-up (25feb2021): new information received from pfizer product quality group includes: investigation results.

Manufacturer Narrative

The root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "burn blisters after using thermacare".The cause of the consumer stating the wrap caused "burn blisters after using thermacare" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.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.

• Brand Name: THERMACARE LOWER BACK & HIP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 11406177
• MDR Text Key: 244303137
• Report Number: 1066015-2021-00028
• 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: 02/18/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: CW8013
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/03/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention