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

Lot Number T48946

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)

Event Date 01/21/2019

Event Type  Injury  

Event Description

Burn blisters [burns second degree].Case narrative: this is a spontaneous report from a contactable consumer.A (b)(6) female patient started to receive thermacare heatwrap (thermacare heatwrap, lot.T48946, expiration date: aug2020), via an unspecified route of administration on (b)(6) 2019 at 1 patch for back pain.The patient medical history was not reported.The patient's concomitant medications were not reported.The patient experienced burn blisters on (b)(6) 2019.The patient reported: "after applying the patch blisters have formed after about 4 hours, which are filled with water.One has already burst!!!" the action taken in response to the event for thermacare heatwrap was unknown.The outcome of the event was not resolved.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the event burns second degree as described is considered serious bodily injury potentially 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.

Event Description

Event verbatim [preferred term] burn blisters [burns second degree] ,.Case narrative: this is a spontaneous report from a contactable consumer.A 47-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), via an unspecified route of administration on (b)(6) 2019 at 1 patch for back pain.The patient medical history included type i diabetes mellitus.Concomitant medication included insulin since 1999 and ongoing.Thermacare was used previously (in (b)(6) 2018 for four days) without problems.Other warming products (not further specified) were used as well in (b)(6) 2018 for one week and were tolerated well.The patient experienced burn blisters on (b)(6) 2019.The patient reported: "after applying the patch blisters have formed after about 4 hours, which are filled with water.One has already burst!!!" the patient was not pregnant and not climacteric.The patient had light skin, not sensitive, had no skin diseases.Thermacare (formulation for back, no lot number provided) was used on (b)(6) 2019 for 5 hours directly on skin, with trousers over it.Event started at 11:00.Event was described as "three big burn blisters.Two of them already resolved, the big one was still present with crust.Wound dressing was applied, inability to work for two days".Treatment (wound care) was received.The skin was controlled during use of thermacare ("once because of burning, the wrap directly removed").Further description of the event: "burn blisters appeared, large wounds, also when the wrap was removed".The was noticed after five hours.The action taken in response to the event for thermacare heatwrap was permanently discontinued on (b)(6) 2019.The outcome of the event was not resolved.Additional information has been requested and will be provided as it becomes available.Follow-up (25feb2019): new information received from the contactable consumer included: suspect product data (trade name, stop date, action taken, deletion of lot number and expiration date), medical history, concomitant medication, past product history, and treatment received.Company clinical evaluation comment: based on the information provided, the event burns second degree as described is 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., comment: based on the information provided, the event burns second degree as described is 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.

Manufacturer Narrative

Investigation summary of pfizer albany investigational report: "the root cause category is non assignable (complaint not confirmed as a quality defect).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.There is not a product quality related trend identified for the subclass of adverse event for lbh products.The 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.The following batches were produced for the germany market: h66740, j01199, j36122, j67196, l16815, l16857, l31419,l44146, l49951, l92682, m13368, m61524, m87697, mn15262, n33570, n49174,n73395, r15191,r47299, r97319, s16661, s16679, s23830,s23831, t38964, t38966, t48910, t48938, t48947 and t69820.There were no quality issues identified in these batches.".

Event Description

Event verbatim [preferred term] burn blisters [burns second degree] ,.Case narrative:this is a spontaneous report from a contactable consumer.A 47-years-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), on 21jan2019 at 1 patch for back pain.The patient medical history included diabetes mellitus type i.Concomitant medication included insulin since 1999 and ongoing.Past product history included thermacare heatwraps (thermacare heatwraps) from mar2018 for four days for an unknown indication with no adverse effect, without problems.Other warming products (not further specified) were used as well in mar2018 for one week and were tolerated well.The patient experienced burn blisters on (b)(6) 2019.The patient reported "after applying the patch blisters have formed after about 4 hours, which are filled with water.One has already burst!!!" the patient was not pregnant and not climacteric.The patient had light skin, not sensitive, had no skin diseases.Thermacare (formulation for back, no lot number provided) was used on (b)(6) 2019 for 5 hours directly on skin, with trousers over it.Event started at 11:00 on (b)(6) 2019.Event was described as "three big burn blisters.Two of them already resolved, the big one was still present with crust.Wound dressing was applied, inability to work for two days".Treatment (wound care) was received.The skin was controlled during use of thermacare ("once because of burning, the wrap directly removed").Further description of the event: "burn blisters appeared, large wounds, also when the wrap was removed".This was noticed after five hours.The action taken in response to the event for thermacare heatwrap was permanently discontined on 21jan2019.The outcome of the event was not resolved.As of 12mar2019, according to the product quality complaint group: investigation summary of pfizer albany investigational report: "the root cause category is non assignable (complaint not confirmed as a quality defect).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.There is not a product quality related trend identified for the subclass of adverse event for lbh products.The 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.The following batches were produced for the germany market: h66740, j01199, j36122, j67196, l16815, l16857, l31419,l44146, l49951, l92682, m13368, m61524, m87697, mn15262, n33570, n49174,n73395, r15191,r47299, r97319, s16661, s16679, s23830,s23831, t38964, t38966, t48910, t48938, t48947 and t69820.There were no quality issues identified in these batches." follow-up (25feb2019): new information received from the contactable consumer included: suspect product data (trade name, stop date, action taken, deletion of lot number and expiration date), medical history, concomitant medication, past product history, and treatment received.Follow-up (12mar2019): new information received from the product quality complaint group includes investigational results.Company clinical evaluation comment: based on the information provided, the event burns second degree as described is 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.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., comment: based on the information provided, the event burns second degree as described is 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.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.

• 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: 8273678
• MDR Text Key: 133977142
• Report Number: 1066015-2019-00016
• 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: consumer,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 01/21/2019

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: 08/01/2020
• Device Lot Number: T48946
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/01/2019; 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INSULIN; INSULIN
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR