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

Lot Number M61524

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Burn, Thermal (2530)

Event Type  Injury  

Event Description

Event verbatim [preferred term] burns on the skin [thermal burn], open wound [wound].Case narrative:this is a spontaneous report from a contactable pharmacist via local product complaint group.A (b)(6) year-old female patient of an unspecified ethnicity started to receive thermacare heatwrap (thermacare lower back & hip) lot: m61524, expiration: may2018, from an unspecified date at an unspecified frequency for an unspecified indication.There were no relevant medical history or concurrent diseases, no concomitant drugs.The patient applied thermacare and in the evening after work and experienced burns on the skin on an unspecified date.The patient was burned by the pad.The physician in the house of pharmacy has performed the first aid.Duration of the event was approximate 4 weeks.No surgery was necessary, treatment: cooling, treatment of open wound.The action taken in response to the event for thermacare heatwrap was unknown.The outcome of the event was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (12mar2018): new information received from the same contactable pharmacist includes: suspect product data (lot number, expiration date).Follow-up (06apr2018): new information included clarification provided by local product quality complaint group: lot number updated.Follow-up (10apr2018): new information received from the contactable consumer includes: patient height and weight, no relevant medical history or no concomitant drugs, and new event "open wound".The case was upgraded to serious.Company clinical evaluation comment: based on the information provided, the events of thermal burn, and wound are as described were 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 thermal burn, and wound are as described were 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.Consumer reports a wrap "caused burned blisters on the skin".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 and technical 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

Burns on the skin/ caused burned blisters on the skin/open wound [burns second degree] ,.Case narrative:this is a spontaneous report from a contactable pharmacist via local product complaint group.A (b)(6) female patient of an unspecified ethnicity started to receive thermacare heatwrap (thermacare lower back and hip) lot: m61524, expiration: may2018, from an unspecified date at an unspecified frequency for an unspecified indication.There were no relevant medical history or concurrent diseases, no concomitant drugs.The patient applied thermacare and in the evening after work and experienced burns on the skin on an unspecified date.The patient was burned by the pad."caused burned blisters on the skin" was also provided in the investigation report.The physician in the house of pharmacy has performed the first aid.Duration of the event was approximate 4 weeks.No surgery was necessary, treatment: cooling, treatment of open wound.The action taken in response to the event for thermacare heatwrap was unknown.The outcome of the event was unknown (pending clarification).According to the product quality complaint 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 a wrap "caused burned blisters on the skin".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 and technical 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 (12mar2018): new information received from the same contactable pharmacist includes: suspect product data (lot number, expiration date).Follow-up (06apr2018): new information included clarification provided by local product quality complaint group: lot number updated.Follow-up (10apr2018): new information received from the contactable consumer includes: patient height and weight, no relevant medical history or no concomitant drugs, and new event "open wound".The case was upgraded to serious.Follow-up (26apr2018): new information received from the product quality complaint group included investigational results and additional event information "caused burned blisters on the skin".Company clinical evaluation comment: based on the information provided, the event of burns second degree is as described were considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event is 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.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the event of burns second degree is as described were considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event is 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.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action 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 a wrap "caused burned blisters on the skin".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 and technical 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

Burns on the skin/ caused burned blisters on the skin/open wound/ burned her back [burns second degree] ,.Case narrative:this is a spontaneous report from a contactable pharmacist via local product complaint group.A (b)(6) female patient started to receive thermacare heatwrap (thermacare lower back and hip) lot: m61524, expiration: may2018, from an unspecified date at an unspecified frequency for an unspecified indication.There were no relevant medical history or concurrent diseases, no concomitant drugs.The patient applied thermacare and in the evening after work and experienced burns on the skin on an unspecified date.The patient was burned by the pad.The patient also reported the product has burned her back."caused burned blisters on the skin" was also provided in the investigation report.The physician in the house of pharmacy has performed the first aid.Duration of the event was approximate 4 weeks.No surgery was necessary, treatment: cooling, treatment of open wound.The action taken in response to the event for thermacare heatwrap was unknown.The outcome of the event was unknown (pending clarification).According to the product quality complaint 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 a wrap "caused burned blisters on the skin".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 and technical 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 (12mar2018): new information received from the same contactable pharmacist includes: suspect product data (lot number, expiration date).Follow-up (06apr2018): new information included clarification provided by local product quality complaint group: lot number updated.Follow-up (10apr2018): new information received from the contactable consumer includes: patient height and weight, no relevant medical history or no concomitant drugs, and new event "open wound".The case was upgraded to serious.Follow-up (26apr2018): new information received from the product quality complaint group included investigational results and additional event information "caused burned blisters on the skin".Follow-up (27jun2018): new information received from a contactable consumer included: more event detail "burned her back".Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the information provided, the event of burns second degree is as described were considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event is 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.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the event of burns second degree is as described were considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event is 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.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action 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 Contact: b green ; 235 e42nd street; new york, NY 10017
• MDR Report Key: 7428552
• MDR Text Key: 105401683
• Report Number: 1066015-2018-00053
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2018

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: 05/01/2018
• Device Lot Number: M61524
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/13/2018
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/02/2018; 07/02/2018
• 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): Required Intervention
• Patient Age: 61 YR