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

Lot Number M06672 06/28

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Scar Tissue (2060); Burn, Thermal (2530)

Event Date 10/01/2017

Event Type  Injury  

Event Description

Event verbatim [preferred term] got big burns, still red after three weeks [thermal burn], still scar [scar], thermacare heatwrap had been glued on the hip for approximately 24 hours [device use issue].Case narrative: this is a spontaneous report from a contactable consumer.A (b)(6)-year-old female patient (subscriber's wife) started to receive thermacare heatwrap (thermacare flexible use), batch number m06672 06/28, expiration date may2018, used on the skin from (b)(6) 2017 for pain in hip.The patient medical history was not reported.The patient did not take any concomitant medication.The patient used this adhesive plaster and got big burns, still red after three weeks in (b)(6) 2017.The product was placed on the hip.The thermacare heatwrap had been glued on the hip for approximately 24 hours.The patient reported still scar in (b)(6) 2017.The patient was not hospitalized due to the event "got big burns, still red after three weeks".She did not receive any treatment for the event burn or scar.The action taken in response to the event for thermacare heatwrap was unknown.The outcome of "got big burns, still red after three weeks" was resolved in 2017.The outcome of "still scar" was not resolved.The outcome of "thermacare heatwrap had been glued on the hip for approximately 24 hours" was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (28nov2017): new information received from a contactable consumer includes: device start date, indication, no concomitant medication, updated event start date and outcome, added new event "still scar" and "thermacare heatwrap had been glued on the hip for approximately 24 hours".The case is updated to serious.Company clinical evaluation comment: based on the information provided, the events of "got big burns, still red" "scar" "thermacare heatwrap had been glued on the hip for approximately 24 hours" 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 of "got big burns, still red" "scar" "thermacare heatwrap had been glued on the hip for approximately 24 hours" 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

Investigation summary: the root cause category is non-assignable (complaint not confirmed).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.After a review of the batch thermal records, thermal results all met product release criteria.The cause of the wrap being too hot is inconclusive since review of records does not provide evidence to support defective product.Care should be taken to read and follow all safety and use information as provided with the wrap to avoid the risk of burns and other skin irritations.The product effect may vary with each individual.The product quality for the batch is not impacted by this complaint.

Event Description

Event verbatim [preferred term] got big burns, still red after three weeks [thermal burn] , still scar [scar] , thermacare heatwrap had been glued on the hip for approximately 24 hours [device use error] ,.Case narrative:this is a spontaneous report from a contactable consumer.A (b)(6) female patient (subscriber's wife) started to receive thermacare heatwrap (thermacare flexible use), batch number m06672 06/28, expiration date may2018, date of manufacture: 28jun2015, used on the skin from (b)(6) 2017 for pain in hip.The patient medical history was not reported.The patient did not take any concomitant medication.The patient used this adhesive plaster and got big burns, still red after three weeks in (b)(6) 2017.The product was placed on the hip.The thermacare heatwrap had been glued on the hip for approximately 24 hours.The patient reported still scar in (b)(6) 2017.The patient was not hospitalized due to the event "got big burns, still red after three weeks".She did not receive any treatment for the event burn or scar.The heatwrap was discarded by the patient.The action taken in response to the event for thermacare heatwrap was unknown.The outcome of "got big burns, still red after three weeks" was resolved in 2017.The outcome of "still scar" was not resolved.The outcome of "thermacare heatwrap had been glued on the hip for approximately 24 hours" was unknown.According to the product quality complaint group: investigation summary: the root cause category is non-assignable (complaint not confirmed).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.After a review of the batch thermal records, thermal results all met product release criteria.The cause of the wrap being too hot is inconclusive since review of records does not provide evidence to support defective product.Care should be taken to read and follow all safety and use information as provided with the wrap to avoid the risk of burns and other skin irritations.The product effect may vary with each individual.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 (28nov2017): new information received from a contactable consumer includes: device start date, indication, no concomitant medication, updated event start date and outcome, added new event "still scar" and "thermacare heatwrap had been glued on the hip for approximately 24 hours".The case is updated to serious.Follow-up (27nov2017): new information received from product quality complaint group includes investigation results., comment: based on the information provided, the events of "got big burns, still red", "scar", and "thermacare heatwrap had been glued on the hip for approximately 24 hours" 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.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.In the case narrative there is evidence of device use error which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time.

• Brand Name: THERMACARE FLEXIBLE USE
• 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: 7066662
• MDR Text Key: 93187316
• Report Number: 1066015-2017-00169
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/13/2017

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: M06672 06/28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/29/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2015
• 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: 97 YR