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

Lot Number L44146

Device Problem Temperature Problem (3022)

Patient Problems Burn(s) (1757); Pain (1994)

Event Date 03/11/2016

Event Type  Injury  

Event Description

Severe pain and burning (grade 2) on back [burns second degree].Severe pain and burning (grade 2) on back [pain].Case description: this is a spontaneous report from a contactable pharmacist received via drug commission of (b)(6).An approximately (b)(6) years old male patient used thermacare heatwrap (thermacare lower back & hip), (device lot number l44146, expiration date mar 2018), on (b)(6) 2016 for back pain.The patient medical history and concomitant medications were not reported.After several hours, the patient experienced severe pain and burning (grade 2) on back.The patient described himself as not heat sensitive and he did not lie on his back.He used the patch from noon to afternoon.The burns were treated by a nurse and were resolving.It was reported that the patient was temporarily severely impaired.The action taken with thermacare heatwrap was permanently withdrawn on (b)(6) 2016.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the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 'severe pain and burning (grade 2) on back' as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events of 'severe pain and burning (grade 2) on back' as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.

Manufacturer Narrative

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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.

Event Description

Case description: this is a spontaneous report from a contactable pharmacist received via drug commission of (b)(6) pharmacist and the (b)(6).An approximately 50-55 years old male patient used thermacare heatwrap (thermacare lower back & hip), (device lot number l44146, expiration date mar2018), on (b)(6) 2016 for back pain.The patient medical history and concomitant medications were not reported.After several hours, the patient experienced severe pain and burning (grade 2) on back.The patient described himself as not heat sensitive and he did not lie on his back.He used the patch from noon to afternoon.The burns were treated by a nurse and were resolving.It was reported that the patient was temporarily severely impaired.The action taken with thermacare heatwrap was permanently withdrawn on (b)(6) 2016.According to the product quality complaint group: 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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Additional information has been requested and will be provided as it becomes available.Follow-up (14apr2016): new information received from the product quality complaint group included investigation results.Follow up (21apr2016): this follow up is being submitted to amend previously reported information.(b)(4).Company clinical evaluation comment: based on the information provided, the events of 'severe pain and burning (grade 2) on back' as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.No device malfunction has been identified.This case meets follow-up10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events of 'severe pain and burning (grade 2) on back' as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.No device malfunction has been identified.This case meets follow-up10-day eu and 30-day fda reportability.Evaluation summary: 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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.

Event Description

Severe pain and burning (grade 2) with blistering on back [burns second degree].Severe pain and burning (grade 2) on back [pain].Case description: this is a spontaneous report from a contactable pharmacist received via (b)(4) (regulatory authority report number (b)(4).An approximately (b)(6) year-old male patient used thermacare heatwrap (thermacare lower back & hip).(device lot number: l44146, expiration date: mar2018) on (b)(6) 2016 for back pain.The patient's medical history and concomitant medications were not reported.On (b)(6) 2016, the patient reported after several hours of using the heatwrap, he experienced severe pain and burning (grade 2) with blistering on his back.The patient described himself as not heat sensitive and he did not lie on his back.He used the patch from noon until the afternoon.It was reported the patient was temporarily severely impaired.Action taken with thermacare heatwrap was permanently withdrawn on (b)(6) 2016.Therapeutic measures taken included unspecified treatment by a registered nurse (rn).No surgery was required as a result of the events.Clinical outcome of the events was resolved on an unspecified date in 2016.According to the product quality complaint group: 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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Additional information has been requested and will be provided as it becomes available.Follow-up (14apr2016): new information received from the product quality complaint group included investigation results.Follow up (21apr2016): this follow up is being submitted to amend previously reported information.The regulatory authority report number in the narrative was updated from (b)(4).Follow up (27apr2017): new information received from a contactable pharmacist includes: events outcome.Follow-up attempts completed.No further information expected.Company clinical evaluation comment: based on the information provided, the events of 'severe pain and burning (grade 2) with blistering on his back' as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.No device malfunction has been identified.This case meets follow-up 10-day eu and 30-day fda reportability.

Event Description

Case description: this is a spontaneous report from a contactable pharmacist received via (b)(6) regulatory authority (b)(4).An approximately (b)(6) male patient used thermacare heatwrap (thermacare lower back & hip) (device lot number: l44146, expiration date: mar2018) on (b)(6) 2016 for back pain.The patient's medical history and concomitant medications were not reported.On (b)(6) 2016, the patient reported after several hours of using the heatwrap, he experienced severe pain and burning (grade 2) with blistering on his back.The patient described himself as not heat sensitive and he did not lie on his back.He used the patch from noon until the afternoon.It was reported the patient was temporarily severely impaired.Action taken with thermacare heatwrap was permanently withdrawn on (b)(6) 2016.Therapeutic measures taken included unspecified treatment by a registered nurse (rn).No surgery was required as a result of the events.Clinical outcome of the events was resolved on an unspecified date in 2016.According to the product quality complaint group: 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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Additional information has been requested and will be provided as it becomes available.Follow-up (14apr2016): new information received from the product quality complaint group included investigation results.Follow up (21apr2016): this follow up is being submitted to amend previously reported information.The regulatory authority report number in the narrative was updated from (b)(4).Follow up (27apr2016): new information received from a contactable pharmacist includes: events outcome.Follow-up (04may2016): this follow-up report is being submitted to amend previously reported information: company clinical evaluation comment and case comment updated to reflect this is a final report.Follow-up attempts completed.No further information expected.Company clinical evaluation comment: based on the information provided, the events of 'severe pain and burning (grade 2) with blistering on his back' as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.No device malfunction has been identified.This case meets final 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events of 'severe pain and burning (grade 2) with blistering on his back' as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.No device malfunction has been identified.This case meets final 10-day eu and 30-day fda reportability.

• Brand Name: THERMACARE LOWER BACK & HIP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; albany GA
• Manufacturer (Section G): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• Manufacturer Contact: b green ; 235 e42nd street; new york, NY 10017 ; 2127334552
• MDR Report Key: 5588116
• MDR Text Key: 43157447
• Report Number: 1066015-2016-00062
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/06/2016

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: 03/01/2018
• Device Lot Number: L44146
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2016
• Initial Date FDA Received: 04/20/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 04/21/2016; 05/06/2016; 05/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 53 YR