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

Lot Number W91242

Device Problems Use of Device Problem (1670); Defective Device (2588)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Type  Injury  

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.Consumer reports, ¿the burn was a full thickness burn," 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.Care should be taken when using the device, 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.A trend does not exist for this batch.Site sample status: not received.

Event Description

The burn was a full thickness burn, on the abdomen, and required surgery to repair it [burns third degree], burn on abdomen/the wrap was the large to extra large size/this is user error [device use error].Case narrative: this is a spontaneous report from a contactable consumer.A (b)(6)-years-old female patient started to receive thermacare heatwrap (thermacare lower back & hip),l/xl device lot number w91242, expiration date 31aug2021, from an unspecified date, for an unspecified indication.Medical history and concomitant medications were not reported.The patient was in the hospital, for a reason the reporter does not wish to specify.The patient was discharged, she believes, on (b)(6) 2019, and has recovered with lasting effects, as the patient needs more treatment "for what is in the moderate range of injury".The burn was a full thickness burn, on the abdomen and required surgery to repair it.The wrap was the large to extra large size.She refers to the ones used in the hospital, it says lower back and hip heat wrap.The wrap used on the patient was not saved.She provides product information from one of the wraps she has from the hospital, but does not have the box to provide a upc and udi number.She said, in looking at this, she (b)(6) burns with thermacare, and the recall notice came up with the thermacare heat wraps, and this one was not on the recall list, so she (b)(6) this product, and (site name) came up as a place consumer can get this, so this one was not a problem.She wants to be clear that there was nothing wet, nothing leaking, and the burn was the size of the area, and the facility was outside of protocol, and this is user error.Regarding dose, she said there were two wraps on the table, so whether it was one at a time, she is not sure.It was applied once over the few hour time period.She would like to make note it is known user error, there was no leaking, nothing was wet, but there were a few previous recalls, and this was not in the nov recall.The action taken with thermacare heatwrap was not reported.The outcome of 'the burn was a full thickness burn, on the abdomen, and required surgery to repair it' was recovered with sequelae and the remaining event was not reported.Per the product quality group: 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.Consumer reports, "the burn was a full thickness burn,"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.Care should be taken when using the device, 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.A trend does not exist for this batch.Site sample status: not received, comment: based on the information provided, the complaints of "full thickness burn on abdomen and alleged user error" as described are considered serious bodily injury requiring surgical and medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and events cannot be ruled out.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.A trend does not exist for this batch.No further investigations or actions is suggested at this time.

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.Consumer reports, ¿the burn was a full thickness burn," 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.Care should be taken when using the device, 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.A trend does not exist for this batch.Site sample status: not received.

Event Description

Event verbatim [preferred term], burn on abdomen/the wrap was the large to extra large size/this is user error [device use error], the burn was a full thickness burn, on the abdomen, and required surgery to repair it [burns third degree], narrative: this is a spontaneous report from a contactable consumer.A (b)(6)-years-old female patient started to receive thermacare heatwrap (thermacare lower back & hip),l/xl device lot number w91242 , expiration date 31aug2021, from an unspecified date, for an unspecified indication.Medical history and concomitant medications were not reported.The patient was in the hospital, for a reason the reporter does not wish to specify.The patient was discharged, she believes, on (b)(6) 2019, and has recovered with lasting effects, as the patient needs more treatment "for what is in the moderate range of injury".The burn was a full thickness burn, on the abdomen and required surgery to repair it.The wrap was the large to extra large size.She refers to the ones used in the hospital, it says lower back and hip heat wrap.The wrap used on the patient was not saved.She provides product information from one of the wraps she has from the hospital, but does not have the box to provide a upc and udi number.She said, in looking at this, she googled burns with thermacare, and the recall notice came up with the thermacare heat wraps, and this one was not on the recall list, so she googled this product, and (site name) came up as a place consumer can get this, so this one was not a problem.She wants to be clear that there was nothing wet, nothing leaking, and the burn was the size of the area, and the facility was outside of protocol, and this is user error.Regarding dose, she said there were two wraps on the table, so whether it was one at a time, she is not sure.It was applied once over the few hour time period.She would like to make note it is known user error, there was no leaking, nothing was wet, but there were a few previous recalls, and this was not in the nov recall.The action taken with thermacare heatwrap was not reported.The outcome of 'the burn was a full thickness burn, on the abdomen, and required surgery to repair it' was recovered with sequelae and the remaining event was not reported.Per the product quality group: 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.Consumer reports, "the burn was a full thickness burn,"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.Care should be taken when using the device, 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.A trend does not exist for this batch.Site sample status: not received.Severity of harm was s3.Follow-up (01apr2020): follow-up attempts completed.No further information expected.Follow -up (22may2020): new information received from product quality complaint group included: severity of harm., comment: based on the information provided, the complaints of "full thickness burn on abdomen and alleged user error" as described are considered serious bodily injury requiring surgical and medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and events cannot be ruled out.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.A trend does not exist for this batch.No further investigations or actions is suggested at this time.

• 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
• Manufacturer (Section G): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• Manufacturer Contact: stella pietrafesa ; 235 e42nd street; new york, NY 10017
• MDR Report Key: 9714660
• MDR Text Key: 179784700
• Report Number: 1066015-2020-00044
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/17/2020

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: 08/31/2021
• Device Lot Number: W91242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 43 YR
• Patient Weight: 557