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

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Pain (1994); Scarring (2061); Swelling (2091); Patient Problem/Medical Problem (2688); Partial thickness (Second Degree) Burn (2694)

Event Date 07/20/2018

Event Type  Injury  

Event Description

Severely burned on cheek buttocks on both sides/blisters on butt cheeks right on the hip [burns second degree], sores hurting [skin lesion], scabs [scab], fall occurred while using thermacare [fall].Case narrative: this is a spontaneous report from a contactable consumer reported for father.An (b)(6) -year-old male patient started to receive thermacare heatwrap (thermacare lower back & hip) via an unspecified route of administration from an unspecified date to an unspecified date at one heat wrap around waist and velcroed one day on and one day off for lower back pain.Medical history included difficulty walking and falling.Concomitant medications were none.Reporter said that she received a recall on thermacare sheets from pfizer.The patient was actually severely burned on his buttocks on (b)(6) 2018.He had blisters.He had it around his waist and that it burned his cheek buttocks on both sides.He had the sheet wrapped completely around his back, the big one.He had used it on other occasions and had not had this happen.There were 3 boxes in one pack.Reporter got them from (pharmacy address).The patient was once burned twice shy.Reporter saw the recall and thought that they needed to know where things went.Reporter called let them know that there was a tainted batch at that (pharmacy name) and that they need to get them out of the stores.Reporter said that they need to get it together because old people use this stuff and that they have thin skin.The patient had back pain from falling.He had difficulty walking.He used the heat wraps for the back pain from the fall rather than going to the emergency room and fell again on (b)(6) 2018.Reporter took to him to the emergency room and he still had blisters on his buttocks.Reporter said that the blisters were the size of female cysts.Reporter said that they thought that they were bedsores and that she said that he did not lay in bed all day that he had blisters.She said that he did not go to the emergency room until he fell the second time.She said that she did not know if the fall was due to the wraps.She said that it was a combination of things but that the sores did hurt him.He said that they have healed recently and that he had scabs from it.She said that it was still pink like scar.Reporter said that she got them healing.She said that she put neosporin on them and was cleaning them with plain water.The patient wrapped the product around his waist and velcroed it in front of him like as he said a judo belt.He had used the product for years but had stopped.They only lasted for 8 hours.Reporter threw them out.The action taken in response to the events of the product was permanently discontinued.The outcome of severely burned on cheek buttocks on both sides/blisters on butt cheeks right on the hip was resolving.The outcome of sores hurting was resolved with sequel.The outcome of other events 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 of "burn blisters" "skin lesion" and "scab" 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 event "fall" is non-serious., comment: based on the information provided, the events of "burn blisters" "skin lesion" and "scab" 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 event "fall" is non-serious.

Event Description

Event verbatim [preferred term].Severely burned on cheek buttocks on both sides/blisters on butt cheeks right on the hip/sores hurting/scabs [burns second degree].Case narrative:this is a spontaneous report from a contactable consumer reported for father.An 86-year-old male patient started to receive thermacare heatwrap (thermacare lower back & hip) via an unspecified route of administration from an unspecified date to an unspecified date at one heat wrap around waist and velcroed one day on and one day off for lower back pain.Medical history included difficulty walking and falling.Concomitant medications were none.Reporter said that she received a recall on thermacare sheets from pfizer.The patient was actually severely burned on his buttocks on (b)(6) 2018.He had blisters.He had it around his waist and that it burned his cheek buttocks on both sides.He had the sheet wrapped completely around his back, the big one.He had used it on other occasions and had not had this happen.There were 3 boxes in one pack.Reporter got them from (pharmacy address).The patient was once burned twice shy.Reporter saw the recall and thought that they needed to know where things went.Reporter called let them know that there was a tainted batch at that (pharmacy name) and that they need to get them out of the stores.Reporter said that they need to get it together because old people use this stuff and that they have thin skin.The patient had back pain from falling.He had difficulty walking.He used the heat wraps for the back pain from the fall rather than going to the emergency room and fell again on (b)(6) 2018.Reporter took to him to the emergency room and he still had blisters on his buttocks.Reporter said that the blisters were the size of female cysts.Reporter said that they thought that they were bedsores and that she said that he did not lay in bed all day that he had blisters.She said that he did not go to the emergency room until he fell the second time.She said that she did not know if the fall was due to the wraps.She said that it was a combination of things but that the sores did hurt him.He said that they have healed recently and that he had scabs from it.She said that it was still pink like scar.Reporter said that she got them healing.She said that she put neosporin on them and was cleaning them with plain water.The patient wrapped the product around his waist and velcroed it in front of him like as he said a judo belt.He had used the product for years but had stopped.They only lasted for 8 hours.Reporter threw them out.The action taken in response to the events of the product was permanently discontinued.The outcome of severely burned on cheek buttocks on both sides/blisters on butt cheeks right on the hip was resolving.The outcome of severely burned on cheek buttocks on both sides/blisters on butt cheeks right on the hip/sores hurting/scabs was recovering.The outcome of other event was unknown.Additional information has been requested and will be provided as it becomes available.Follow up (17feb2020): new information received from a product quality complaint group includes: investigation is still in progress.Malfunction updated to blank accordingly.Events sores hurting and scabs deleted and subsumed under event burns second degree., comment: based on the information provided, the events of burns second degree as described was considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the suspect device and the events cannot be ruled out.The event "fall" was assessed as non-serious and not associated with the use of the device.

Event Description

Event verbatim [preferred term].Severely burned on cheek buttocks on both sides/blisters on butt cheeks right on the hip/sores hurting/scabs [burns second degree], fall occurred while using thermacare [fall].Narrative: this is a spontaneous report from a contactable consumer reported for father.An 86-year-old male patient started to receive thermacare heatwrap (thermacare lower back & hip) via an unspecified route of administration from an unspecified date to an unspecified date at one heat wrap around waist and velcroed one day on and one day off for lower back pain.Medical history included difficulty walking and falling.Concomitant medications were none.Reporter said that she received a recall on thermacare sheets from pfizer.The patient was actually severely burned on his buttocks on (b)(6) 2018.He had blisters.He had it around his waist and that it burned his cheek buttocks on both sides.He had the sheet wrapped completely around his back, the big one.He had used it on other occasions and had not had this happen.There were 3 boxes in one pack.Reporter got them from (pharmacy address).The patient was once burned twice shy.Reporter saw the recall and thought that they needed to know where things went.Reporter called let them know that there was a tainted batch at that (pharmacy name) and that they need to get them out of the stores.Reporter said that they need to get it together because old people use this stuff and that they have thin skin.The patient had back pain from falling.He had difficulty walking.He used the heat wraps for the back pain from the fall rather than going to the emergency room and fell again on (b)(6) 2018.Reporter took to him to the emergency room and he still had blisters on his buttocks.Reporter said that the blisters were the size of female cysts.Reporter said that they thought that they were bedsores and that she said that he did not lay in bed all day that he had blisters.She said that he did not go to the emergency room until he fell the second time.She said that she did not know if the fall was due to the wraps.She said that it was a combination of things but that the sores did hurt him.He said that they have healed recently and that he had scabs from it.She said that it was still pink like scar.Reporter said that she got them healing.She said that she put neosporin on them and was cleaning them with plain water.The patient wrapped the product around his waist and velcroed it in front of him like as he said a judo belt.He had used the product for years but had stopped.They only lasted for 8 hours.Reporter threw them out.The action taken in response to the events of the product was permanently discontinued.The outcome of severely burned on cheek buttocks on both sides/blisters on butt cheeks right on the hip/sores hurting/scabs was recovering.The outcome of other event was unknown.According to product quality complaint group, this investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.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 adverse event safety request for investigation.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.Lot trend assessment and rationale: a lot trend was not performed as the lot number is unknown.Site sample status was not received.Follow up (17feb2020): new information received from a product quality complaint group includes: investigation is still in progress.Malfunction updated to blank accordingly.Events sores hurting and scabs deleted and subsumed under event burns second degree.Follow-up (14apr2020): new information received from a product quality complaint group included: investigation result.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the event of burns second degree as described was considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the suspect device and the events cannot be ruled out.The event "fall" was assessed as non-serious and not 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

This investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.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 adverse event safety request for investigation.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.Lot trend assessment and rationale: a lot trend was not performed as the lot number is unknown.Site sample status was not received.

• 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: 8016195
• MDR Text Key: 125433206
• Report Number: 1066015-2018-00123
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 10/15/2018

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/29/2018
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/05/2020; 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Weight: 73