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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Skin Discoloration (2074); Burn, Thermal (2530); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Event Description

Lesions, like "burn" in the lumbar area/these lesions were red but some were black as if they were necrotized/she has had them for 20 days [skin lesion], [erythema], [skin discolouration].Case narrative: this is a spontaneous report from a contactable health care professional (midwife) received via a sales representative.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip), via an unspecified route of administration from an unspecified date to an unspecified date at an unspecified dose for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient showed to the midwife lesions, like "burn", in the lumbar area where she had applied thermacare back.These lesions were red but some were black as if they were necrotized.The patient asked to the midwife if these lesions could be definitive since she has had them for 20 days.The action taken in response to the event for thermacare heatwrap was unknown.The outcome of the event was not resolved.Company clinical evaluation comment: based on the information provided, the events of "lesions, like 'burn' in the lumbar area/ these lesions were red but some were black as if they were necrotized/ she has had them for 20 days" 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.

Event Description

Event verbatim [preferred term] lesions, like burn in the lumbar area/ these lesions were red but some were black as if they were necrotized/ she has had them for 20 days [skin lesion] , lesions, like burn in the lumbar area/ these lesions were red but some were black as if they were necrotized/ she has had them for 20 days [erythema] , lesions, like burn in the lumbar area/ these lesions were red but some were black as if they were necrotized/ she has had them for 20 days [skin discolouration] ,.Case narrative:this is a spontaneous report from a contactable health care professional (midwife) received via a sales representative.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip), via an unspecified route of administration from an unspecified date to an unspecified date at an unspecified dose for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient showed to the midwife lesions, like burn, in the lumbar area where she had applied thermacare back.These lesions were red but some were black as if they were necrotized.The patient asked to the midwife if these lesions could be definitive since she has had them for 20 days.The action taken in response to the event for thermacare heatwrap was unknown.The outcome of the event was not resolved.According to product quality complaint group: the root cause category is non-assignable (not confirmed as a quality defect).Our manufacturing operations employ quality control procedures which include in-process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.There is not a trend identified for the subclass of adverse event for lbh products.There is not a trend identified for the subclass of adverse event for lbh products, adverse event lbh(b)(6) - 2016 - (b)(6) 2019 trending graph.Adverse events for burns show peaks in (b)(6) 2018 thru (b)(6) 2019.Thermacare burn rate surveillance was included in management review on 23-jan-2019.In the most recent 6 month period((b)(6) 2018), the burn cases/million wraps continues to be very stable at 3.61 less than maximum [<10].No trend; the burn rate is within ppm.Follow-up (22feb2019): new information received from product quality complaint group includes investigation results., comment: based on the information provided, the events of "lesions, like burn in the lumbar area/ these lesions were red but some were black as if they were necrotized/ she has had them for 20 days" 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.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time.

Manufacturer Narrative

The root cause category is non-assignable (not confirmed as a quality defect).Our manufacturing operations employ quality control procedures which include in-process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.There is not a trend identified for the subclass of adverse event for lbh products.There is not a trend identified for the subclass of adverse event for lbh products, refer to attachment adverse event lbh (b)(6) 2016 - (b)(6) 2019 trending graph.Adverse events for burns show peaks in (b)(6) 2018 thru (b)(6) 2019.Thermacare burn rate surveillance was included in management review on (b)(6) -2019.In the most recent 6 month period(jun-dec 2018), the burn cases/million wraps continues to be very stable at 3.61 less than maximum [<10].No trend; the burn rate is within ppm.

• 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: 8281515
• MDR Text Key: 134237892
• Report Number: 1066015-2019-00021
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention