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

Lot Number AP4310

Device Problems Difficult to Remove (1528); Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Partial thickness (Second Degree) Burn (2694)

Event Date 02/03/2020

Event Type  Injury  

Event Description

Suffers from pain and has three open burns in her lumbar region [burns second degree], problems occurred because the heat wrap stuck to the back [device adhesion issue].Case narrative: this is a spontaneous report from a contactable pharmacist received via (b)(6), regulatory authority number (b)(4).An approximately (b)(6) female patient used thermacare (thermacare lower back & hip), device lot number ap4310, at an unspecified frequency from an unspecified date for an unspecified indication.Medical history and concomitant medications were not reported.On (b)(6) 2020 she experienced burn blister on her back.According to the reporter, the heat wrap for lower back was worn during the day during working hours.When the heat wrap was taken off in the evening, problems occurred because the heat wrap stuck to the back.It was found that underneath the heat wrap burns with burn blisters had developed which opened up when the wrap was removed.The patient suffers from pain and has three open burns in her lumbar region.She had used heat wraps from the same manufacturer for some time and had never had any problems.She never felt that the heat wrap was particularly hot and she also had not used any new medications which may have altered the condition of her skin.The action taken with thermacare heatwrap and event outcome were not reported.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the events burns second degree and device adhesion issue as described are considered serious bodily injury potentially 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 burns second degree and device adhesion issue as described are considered serious bodily injury potentially 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

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 she had "burn blisters." the cause of the consumer stating the wrap caused burn blisters 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.Reasonably suggest device malfunction: no.Site sample status: not received.

Event Description

Event verbatim [preferred term] suffers from pain and has three open burns in her lumbar region [burns second degree] , problems occurred because the heat wrap stuck to the back [device adhesion issue].Case narrative: this is a spontaneous report from a contactable pharmacist received via bfarm health authority, regulatory authority number (b)(4).An approximately 50-year-old female patient used thermacare (thermacare lower back & hip), device lot number ap4310, expiration date: jan2022, at an unspecified frequency from an unspecified date for an unspecified indication.Medical history and concomitant medications were not reported.On (b)(6) 2020 she experienced burn blister on her back.According to the reporter, the heat wrap for lower back was worn during the day during working hours.When the heat wrap was taken off in the evening, problems occurred because the heat wrap stuck to the back.It was found that underneath the heat wrap burns with burn blisters had developed which opened up when the wrap was removed.The patient suffers from pain and has three open burns in her lumbar region.She had used heat wraps from the same manufacturer for some time and had never had any problems.She never felt that the heat wrap was particularly hot and she also had not used any new medications which may have altered the condition of her skin.The action taken with thermacare heatwrap and event outcome were not reported.Product investigation results were as follows: 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 she had "burn blisters." the cause of the consumer stating the wrap caused burn blisters 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.Reasonably suggest device malfunction: no.Site sample status: not received.Follow-up (25feb2020): new information received from citi includes product investigation results and expiration date.

Event Description

Event verbatim [preferred term] suffers from pain and has three open burns in her lumbar region [burns second degree] , problems occurred because the heat wrap stuck to the back [device adhesion issue].Case narrative:this is a spontaneous report from a contactable pharmacist received via bfarm health authority, regulatory authority number (b)(4).An approximately 50-year-old female patient used thermacare (thermacare lower back & hip), device lot number ap4310, expiration date: jan2022, at an unspecified frequency from an unspecified date for an unspecified indication.Medical history and concomitant medications were not reported.On (b)(6) 2020 she experienced burn blister on her back.According to the reporter, the heat wrap for lower back was worn during the day during working hours.When the heat wrap was taken off in the evening, problems occurred because the heat wrap stuck to the back.It was found that underneath the heat wrap burns with burn blisters had developed which opened up when the wrap was removed.The patient suffers from pain and has three open burns in her lumbar region.She had used heat wraps from the same manufacturer for some time and had never had any problems.She never felt that the heat wrap was particularly hot and she also had not used any new medications which may have altered the condition of her skin.The action taken with thermacare heatwrap and event outcome were not reported.Product investigation results were as follows: 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 she had "burn blisters." the cause of the consumer stating the wrap caused burn blisters 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.Reasonably suggest device malfunction: yes.Site sample status: not received.Severity of harm: s3.Follow-up (25feb2020): new information received from citi includes product investigation results and expiration date.Follow-up (30mar2020): new information received from a product quality complaint group includes: investigation summary, manufacturing site severity and malfunction assessment provided.

Manufacturer Narrative

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 she had "burn blisters." the cause of the consumer stating the wrap caused burn blisters 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.Reasonably suggest device malfunction: yes.Site sample status: not received.Severity of harm: s3.

Manufacturer Narrative

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 she had "burn blisters." the cause of the consumer stating the wrap caused burn blisters 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.Reasonably suggest device malfunction: yes.Site sample status: not received.

Event Description

Event verbatim [preferred term].Suffers from pain and has three open burns in her lumbar region/ a visible scar might develop [burns second degree], problems occurred because the heat wrap stuck to the back [device adhesion issue].Narrative: this is a spontaneous report from a contactable pharmacist received via bfarm health authority, regulatory authority number (b)(4).An approximately 50-year-old female patient used thermacare heatwrap (thermacare lower back & hip), device lot number ap4310, expiration date: jan2022, at an unspecified frequency from an unspecified date for back pain.Medical history included hypertension.Ongoing concomitant medication included hydrochlorothiazide; metoprolol succinate (metoprolol succinat 1a plus) and ramipril (ramilich) both for hypertension.The patient previously took contraceptive dienogest;ethinylestradiol (maxim).On (b)(6) 2020 she experienced burn blister on her back.According to the reporter, the heat wrap for lower back was worn during the day during working hours.When the heat wrap was taken off in the evening, problems occurred because the heat wrap stuck to the back.It was found that underneath the heat wrap burns with burn blisters had developed which opened up when the wrap was removed.The patient suffers from pain and has three open burns in her lumbar region.She had used heat wraps from the same manufacturer (thermacare heatwrap) for some time and had never had any problems.She never felt that the heat wrap was particularly hot and she also had not used any new medications which may have altered the condition of her skin.It is further reported that thermacare with lot number ap4310, had been used once for 8 hours on (b)(6) 2020, due to back pain as self medication.The female consumer applied the thermacare heat wraps often.She applied it during the working hours in the office on the specific day.She had problems to remove it in the evening because the heat wrap was "glued" to her back.She realized later that burns and burn blisters had developed under the heat wrap which opened when the heat wrap has been removed.She was in pain.The wound healed in the meantime, a visible scar might develop.The event had been assessed as non-serious by the consumer.No surgery was required.Self medication with gel for burns and wounds and later betaisodonna was required.The action taken in response to the event for thermacare heatwrap was unknown.The outcome of the events was recovering.Product investigation results were as follows: 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 she had "burn blisters." the cause of the consumer stating the wrap caused burn blisters 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.Reasonably suggest device malfunction was yes.Site sample status was not received.Severity of harm was s3.Follow-up (25feb2020): new information received from citi includes product investigation results and expiration date.Follow-up (30mar2020): new information received from a product quality complaint group includes: investigation summary, manufacturing site severity and malfunction assessment provided.Follow-up (15apr2020): follow-up attempts completed.No further information expected.Follow-up (22ap2020): new information received from the contactable pharmacist includes: medical history and concomitant medication, product indication, event details (including seriousness assessment, treatment and outcome).

• 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: 9776159
• MDR Text Key: 189457329
• Report Number: 1066015-2020-00051
• 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,Followup,Followup
• Report Date: 02/17/2020

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2022
• Device Lot Number: AP4310
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/02/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/10/2020; 04/13/2020; 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: METOPROLOL SUCCINAT 1A PLUS [DOSAGE FORM:] TABLET.; RAMILICH [DOSAGE FORM:].
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 58