MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE NECK, SHOULDER & WRIST; DISPOSABLE PACK, HOT

Device Problem Use of Device Problem (1670)

Patient Problems Unspecified Infection (1930); Full thickness (Third Degree) Burn (2696)

Event Date 03/25/2017

Event Type  Injury  

Event Description

Third degree burns/ burn that going to last for a month [burns third degree] , did not look at the back of the product but i put it on overnight [device use error] , infection [infection] ,.Case narrative:this is a spontaneous report from a contactable consumer.A patient of unspecified age ethnicity and gender started to receive thermacare heatwrap (thermacare heatwrap), via an unspecified route of administration from an unspecified date for pulled muscle in the leg.The patient medical history and concomitant medications were not reported.The patient mentioned put on the product, did not look at the back of the product but put it on overnight.The patient subsequently received third degree burns.The patient has now been to the doctors.The patient was on some medications for infection."i am completely 'banished' up with doctor's it cost me (b)(6) and i think it's terrible even if you have instructions on it that you put a product in stores that can cause such an enormous damage".The patient also mentioned "i have a burn that is going to last for a month".The action taken for the product and events outcome 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 event "did not look at the back of the product but put it on overnight, subsequently received third degree burns and infection" as described in this case are considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event are assessed as associated with the use of the device., comment: based on the information provided, the event "did not look at the back of the product but put it on overnight, subsequently received third degree burns and infection" as described in this case are considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event are assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term] third degree burns/ burn that going to last for a month [burns third degree], did not look at the back of the product but i put it on overnight [wrong technique in device usage process], infection [infection].Case narrative:this is a spontaneous report from a contactable consumer.A patient of unspecified age ethnicity and gender started to use thermacare heatwrap (thermacare heatwrap) from an unspecified date for pulled muscle in the leg.The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient reported she put on the product, did not look at the back of the product but put it on overnight.The patient subsequently received third degree burns.The patient has now been to the doctors.The patient was on some medications for infection."i am completely 'banished' up with doctor's, it cost me (b)(6) and i think it's terrible even if you have instructions on it that you put a product in stores that can cause such an enormous damage".The patient also mentioned "i have a burn that is going to last for a month".Action taken with the suspect product was unknown.Therapeutic measures taken included unspecified medications for infection.Clinical outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (05jun2017): this contactable consumer reported by way of medical records.This female patient's relevant medical history included breast cancer (underwent breast lumpectomy in 2000), allergy to tetanus vaccine and allergy to penicillin (had hives) on an unknown date.Her family history was significant for stomach cancer on an unknown date (father).

Event Description

Event verbatim [preferred term] third degree burns/ burn that going to last for a month [burns third degree] , did not look at the back of the product but i put it on overnight [device use error] , infection [infection] , first degree burn/burns/ severe burns on the back of her right leg/erythema/erythema behind right knee/two small blisters [burns second degree] , gait was impaired secondary to the burn [gait disturbance] , pain in back of right knee [arthralgia] , low back pain [back pain] , difficulty in weight bearing right leg [weight bearing difficulty] , pain down right leg [pain in extremity] , i used the thermal care patch on a pulled muscle in my thigh [intentional device use issue] ,.Case narrative:this is a spontaneous report from a contactable consumer.A patient of unspecified age and gender started to use thermacare heatwrap (thermacare heatwrap) from an unspecified date for pulled muscle in the leg.The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient reported she put on the product, did not look at the back of the product but put it on overnight.The patient subsequently received third degree burns.The patient has now been to the doctors.The patient was on some medications for infection."i am completely 'banished' up with doctor's it cost me 200 dollars and i think it's terrible even if you have instructions on it that you put a product in stores that can cause such an enormous damage".The patient also mentioned "i have a burn that is going to last for a month".Action taken with the suspect product was unknown.Therapeutic measures taken included unspecified medications for infection.Clinical outcome of the events was unknown.Follow-up (05jun2017): this contactable consumer reported by way of medical records.This female patient's relevant medical history included breast cancer (underwent breast lumpectomy in 2000), allergy to tetanus vaccine and allergy to penicillin (had hives) on an unknown date.Her family history was significant for stomach cancer on an unknown date (father).Follow-up (11feb2020): this is a follow-up report combining information from duplicate reports (b)(4).The current and all subsequent follow-up information will be reported under manufacturer report number (b)(4).The new information reported from a consumer included patient age (78-year-old), lab data (skin examination on (b)(6) 2017 showed two small blisters over right hamstring/traumatic blister of thigh), suspect product name (thermacare neck, shoulder & wrist), new events (consumer used the product on a pulled muscle in her thigh on (b)(6) 2017 and has enclosed pictures of burns (2017) she received as a result of the patch.Consumer stated she did not think the product should be sold at all.Consumer requested to speak with someone on the telephone as she had already paid more than $500 in medical bills for treatment and consultation.Consumer stated she would be prepared to send a copy of those bills if requested and stated she would be waiting on a response before she contacted her lawyer.In (b)(6) 2017, she suffered from first degree burn.In 2017, she had erythema.It was reported that on (b)(6) 2017, her physical therapist observed severe burns on the back of her right leg and her gait was impaired secondary to the burn.It was reported that on (b)(6) 2017, erythema was demarcated with surgical marker and instructed to consult if erythema spreads beyond the marker.It was reported that she was treated with mupirocin (bactroban) 2 percent ointment.She was treated with neosporin ointment for two small blisters over right hamstring/traumatic blister of thigh.It was reported that her burn was healing.This patient experienced pain in back of right knee, pain down right leg, erythema behind right knee, blistering behind right knee, popliteal space right knee skin red with severe blistering and low back pain and difficulty in weight bearing right leg on an unknown date.It was reported that she received home exercise program (hep) and soft tissue mobilization (stm) to lumbar paraspinals and right peroneal and gastrocnemius muscles followed by gait training and postural correction.It was also reported that gait continues to be impaired secondary to burn posterior aspect right knee and gait improved following massage to gastrocnemius and peroneal muscles).As of (b)(6) 2017, the clinical outcome of the events pain in back of right knee, pain down right leg, low back pain and difficulty in weight bearing right leg was unknown and "gait was impaired secondary to the burn" "burns/ severe burns on the back of her right leg and first degree burn" was recovering.Additional information has been requested and will be provided as it becomes available.

Manufacturer Narrative

Summary of investigation: this investigation was conducted for an unknown lot number neck/shoulder/wrist (nsw) 8 hour product.Conclusion: 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 assmt.& rationale: a lot trend was not performed.The lot number is unknown.The sample had not been received by the site.

Event Description

Event verbatim [preferred term], did not look at the back of the product but i put it on overnight [device use error], third degree burns/ burn that going to last for a month [burns third degree], infection [infection], first degree burn/burns/ severe burns on the back of her right leg/erythema/erythema behind right knee/two small blisters [burns second degree], gait was impaired secondary to the burn [gait disturbance], pain in back of right knee [arthralgia], low back pain [back pain], difficulty in weight bearing right leg [weight bearing difficulty], pain down right leg [pain in extremity], i used the thermal care patch on a pulled muscle in my thigh [intentional device use issue].Narrative: this is a spontaneous report from a contactable consumer.A patient of unspecified age and gender started to use thermacare heatwrap (thermacare heatwrap) from an unspecified date for pulled muscle in the leg.The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient reported she put on the product, did not look at the back of the product but put it on overnight.The patient subsequently received third degree burns.The patient has now been to the doctors.The patient was on some medications for infection."i am completely 'banished' up with doctor's it cost me (b)(4) and i think it's terrible even if you have instructions on it that you put a product in stores that can cause such an enormous damage".The patient also mentioned "i have a burn that is going to last for a month".Action taken with the suspect product was unknown.Therapeutic measures taken included unspecified medications for infection.Clinical outcome of the events was unknown.Follow-up (05jun2017): this contactable consumer reported by way of medical records.This female patient's relevant medical history included breast cancer (underwent breast lumpectomy in 2000), allergy to tetanus vaccine and allergy to penicillin (had hives) on an unknown date.Her family history was significant for stomach cancer on an unknown date (father).Follow-up (11feb2020): this is a follow-up report combining information from duplicate reports (b)(4).The current and all subsequent follow-up information will be reported under manufacturer report number (b)(4).The new information reported from a consumer included patient age (78-year-old), lab data (skin examination on (b)(6) 2017 showed two small blisters over right hamstring/traumatic blister of thigh), suspect product name (thermacare neck, shoulder & wrist), new events (consumer used the product on a pulled muscle in her thigh on (b)(4)2017 and has enclosed pictures of burns (2017) she received as a result of the patch.Consumer stated she did not think the product should be sold at all.Consumer requested to speak with someone on the telephone as she had already paid more than (b)(4) in medical bills for treatment and consultation.Consumer stated she would be prepared to send a copy of those bills if requested and stated she would be waiting on a response before she contacted her lawyer.In (b)(6) 2017, she suffered from first degree burn.In 2017, she had erythema.It was reported that on (b)(6) 2017, her physical therapist observed severe burns on the back of her right leg and her gait was impaired secondary to the burn.It was reported that on (b)(6) 2017, erythema was demarcated with surgical marker and instructed to consult if erythema spreads beyond the marker.It was reported that she was treated with mupirocin (bactroban) 2 percent ointment.She was treated with neosporin ointment for two small blisters over right hamstring/traumatic blister of thigh.It was reported that her burn was healing.This patient experienced pain in back of right knee, pain down right leg, erythema behind right knee, blistering behind right knee, popliteal space right knee skin red with severe blistering and low back pain and difficulty in weight bearing right leg on an unknown date.It was reported that she received home exercise program (hep) and soft tissue mobilization (stm) to lumbar paraspinals and right peroneal and gastrocnemius muscles followed by gait training and postural correction.It was also reported that gait continues to be impaired secondary to burn posterior aspect right knee and gait improved following massage to gastrocnemius and peroneal muscles).As of (b)(6) 2017, the clinical outcome of the events pain in back of right knee, pain down right leg, low back pain and difficulty in weight bearing right leg was unknown and "gait was impaired secondary to the burn" "burns/ severe burns on the back of her right leg and first degree burn" was recovering.Follow-up (02jun2020): new information received from product quality complaints group included: investigation results.Summary of investigation: this investigation was conducted for an unknown lot number neck/shoulder/wrist (nsw) 8 hour product.Conclusion: 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 assmt.& rationale: a lot trend was not performed.The lot number is unknown.The sample had not been received by the site.

• Brand Name: THERMACARE NECK, SHOULDER & WRIST
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 6485186
• MDR Text Key: 72531226
• Report Number: 1066015-2017-00077
• 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,Followup
• Report Date: 04/06/2017

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/12/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 06/09/2017; 02/20/2020; 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR