MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAP; DISPOSABLE PACK, HOT

Lot Number L16815

Device Problem Temperature Problem (3022)

Patient Problems Purulent Discharge (1812); Burn, Thermal (2530)

Event Type  Injury  

Event Description

Burn with discharge of pus [thermal burn].Burn with discharge of pus [purulent discharge].Case description: this is a spontaneous report from a contactable pharmacist received via pfizer consumer healthcare (pch).A male patient of an unspecified age and ethnicity started to use thermacare heatwrap (thermacare heatwrap, lot# l16815), from an unspecified date to an unspecified date at an unspecified frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.On an unspecified date, the patient suffered from burn with discharge of pus requiring unspecified medical care/treatment.The outcome of the events was unknown.The action taken in response to the events for thermacare heatwrap was unknown.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the events burn with discharge of pus 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 (b)(6) and 30-day fda reportability.Case comment: based on the information provided, the events burn with discharge of pus 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 (b)(6) 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 (b)(6) received via pfizer consumer healthcare (pch).A male patient of an unspecified age and ethnicity started to use thermacare heatwrap (thermacare heatwrap) (lot #: l16815) from an unspecified date at an unspecified frequency for an unspecified indication.The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient suffered from burn with discharge of pus requiring unspecified medical care/treatment.Action taken in response to the events for thermacare heatwrap was unknown.Clinical outcome of the events was unknown.New information received from product quality complaint (pqc) group includes investigation results.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 ((b)(6) 2016): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up attempts completed.No further information expected.Company clinical evaluation comment: based on the information provided, the events burn with discharge of pus 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 final 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events burn with discharge of pus 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 final 10-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.

• Brand Name: THERMACARE HEATWRAP
• 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: 5434091
• MDR Text Key: 38134029
• Report Number: 1066015-2016-00018
• 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
• Report Date: 01/25/2016

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 Lot Number: L16815
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2016
• Initial Date FDA Received: 02/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/22/2016
• 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