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

Lot Number N15776

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Rupture (2208); Partial thickness (Second Degree) Burn (2694)

Event Date 11/18/2016

Event Type  Injury  

Event Description

Second degree burns the size of a silver dollar and almost on the right side of the hip, kind of a blister after it has burst, laying on her back on the bed on and off during the 5 hours of heatwrap usage/ did not check her skin under the wrap during usage, laying on her back on the bed on and off during the 5 hours of heatwrap usage/ did not check her skin under the wrap during usage, was hotter than other devices used in the past,.Case narrative:this is a spontaneous report from a contactable consumer or other non hcp.A (b)(6) female patient started to use thermacare heatwrap (thermacare lower back & hip) (device lot number: n15776, expiration date: apr2021) from (b)(6) 2016 for back pain.Medical history included blood pressure abnormal from an unknown date and unknown if ongoing and unspecified back surgeries in 2004 and 2006.Concomitant medication included ongoing labetalol (labetalol), ongoing lovastatin (lovastatin) and ongoing oxycodone (oxycodone).Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.The patient reported she applied the heatwrap for 5 hours and removed it before she went to bed as it started hurting and getting too hot, on friday night, (b)(6) 2016.It was at this time she discovered a second degree burn.She stated she noticed this wrap was hotter compared to others used in the past.The patient stated she was laying on her back on the bed on and off during the 5 hours of heatwrap usage.She used a towel between the heatwrap and her skin.The patient did not check her skin under the wrap during usage.The burn was described as the size of a silver dollar and almost on the right side of the hip.Per the patient's husband, the area was red, with kind of a blister after it has burst.She went to the emergency room on saturday, (b)(6) 2016 where she was treated with antibiotic lotion and an oral antibiotic.The patient was scheduled to follow-up with her primary doctor in one week's time.The patient assessed her skin tone as medium (neither light nor dark, tans very easily).She is currently under the care of a physician for blood pressure and for follow-up on pain medication for back.The patient denied having sensitive skin and denied any abnormal skin conditions.The patient read the usage instructions for the heatwrap prior to use.She did not engage in exercise while using the heatwrap.The patient previously used other heat products for pain relief, reported as aleve tens unit without any adverse effect.Action taken with the suspect product was permanently withdrawn on (b)(6) 2016.Therapeutic measures taken included antibiotic lotion (mupirocin 2% ointment, 22 gm, applied 3 times daily for 10 days) and an antibiotic by mouth (cephalexin 500 mg, 3 times daily for 7 days).Clinical 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 available information, the events of second degree burns and blister rupture after using heatwrap with device issue, and device use error as described in this case is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device., comment: based on the available information, the events of second degree burns and blister rupture after using heatwrap with device issue, and device use error as described in this case is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, 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 and technical 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.Consumer alleges the product is too hot.The cause of the alleged wrap being too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Process related? no.Design related? no.Capas in place? n/a.Manufactured post-capa? n/a.Complaint confirmed? no.Notify safety? no.Conclusion and approvals: additional approval(s) req'd? no.Root cause category (tier 1): non-assignable (complaint not confirmed).Regulatory impact: no.Product quality impact: no.Market / clinical impact: no.Final confirmation status: not confirmed.Stability impact: no.Sqrt review required? no.Aqrt review req'd? no.Submitted on(gmt): (b)(6) 2017.Site qa approval on(gmt): (b)(6) 2017.Closed on(gmt): (b)(6) 2017.

Event Description

Event verbatim [preferred term] second degree burns the size of a silver dollar and almost on the right side of the hip [burns second degree] , kind of a blister after it has burst [blister rupture] , laying on her back on the bed on and off during the 5 hours of heatwrap usage/ did not check her skin under the wrap during usage [intentional device misuse] , laying on her back on the bed on and off during the 5 hours of heatwrap usage/ did not check her skin under the wrap during usage [device use error] , was hotter than other devices used in the past [device issue].Case narrative:this is a spontaneous report from a contactable consumer.A (b)(6) caucasian female patient started to use (b)(6) heatwrap ((b)(6) lower back & hip) (device lot number: n15776, expiration date: apr2021) from (b)(6) 2016 for back pain.Medical history included blood pressure abnormal from an unknown date and unknown if ongoing and unspecified back surgeries in 2004 and 2006.Concomitant medication included ongoing labetalol at 200 mg, 2x/day oral for blood pressure, ongoing lovastatin at 200 mg, 1x/day oral for blood pressure and ongoing oxycodone at 30mg tablet up to 5 times per day as needed for back pain from 2004.Past product history included (b)(6) heatwraps ((b)(6) heatwraps) from an unspecified date for an unspecified indication with no adverse effect.The patient reported she applied the heatwrap for 5 hours and removed it before she went to bed as it started hurting and getting too hot, on friday night, (b)(6) 2016.It was at this time she discovered a second degree burn.She stated she noticed this wrap was hotter compared to others used in the past.The patient stated she was laying on her back on the bed on and off during the 5 hours of heatwrap usage.She used a towel between the heatwrap and her skin.The patient did not check her skin under the wrap during usage.The burn was described as the size of a silver dollar and almost on the right side of the hip.Per the patient's husband, the area was red, with kind of a blister after it has burst.She went to the emergency room on (b)(6) 2016 where she was treated with antibiotic lotion and an oral antibiotic.The patient was scheduled to follow-up with her primary doctor in one week's time.The patient assessed her skin tone as medium (neither light nor dark, tans very easily).She is currently under the care of a physician for blood pressure and for follow-up on pain medication for back.The patient denied having sensitive skin and denied any abnormal skin conditions.The patient read the usage instructions for the heatwrap prior to use.She did not engage in exercise while using the heatwrap.The patient previously used other heat products for pain relief, reported as aleve tens unit without any adverse effect.Action taken with the suspect product was permanently withdrawn on (b)(6) 2016.Therapeutic measures taken included antibiotic lotion ((b)(6), applied 3 times daily for 10 days) and an antibiotic by mouth ((b)(6) 500mg, 3 times daily for 7 days).Clinical outcome of the events second degree burns and blister burst was not resolved, other events outcome was unknown.Product quality investigational results included: investigation summary: the root cause category is non-assignable (complaint not confirmed).The plant has reviewed this batch from a manufacturing and technical 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.Consumer alleges the product is too hot.The cause of the alleged wrap being too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Process related? no.Design related? no.Capas in place? n/a.Manufactured post-capa? n/a.Complaint confirmed? no.Notify safety? no.Conclusion and approvals: additional approval(s) req'd? no.Root cause category (tier 1): non-assignable (complaint not confirmed).Regulatory impact: no.Product quality impact: no.Market / clinical impact: no.Final confirmation status: not confirmed.Stability impact: no.Sqrt review required? no.Aqrt review req'd? no.Submitted on(gmt): (b)(6) 2017.Site qa approval on(gmt): (b)(6) 2017.Closed on(gmt): (b)(6) 2017.Additional information has been requested and will be provided as it becomes available.Follow-up (05jan2017): new information received from a product quality complaints included: product quality investigational results.Company clinical evaluation comment: based on the available information, the events of second degree burns and blister rupture after using heatwrap with device issue, and device use error as described in this case is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device., comment: based on the available information, the events of second degree burns and blister rupture after using heatwrap with device issue, and device use error as described in this case is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, 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 and technical 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.Consumer alleges the product is too hot.The cause of the alleged wrap being too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.This investigation was reopened to add the return sample evaluation results.The wrap returned was not the wrap the consumer complained about (the other wrap that came in the same box).The sample did not provide any additional information as to why the consumer felt the wrap "was hotter compared to others used in the past".The investigation summary nor the root cause changed as a result of the returned sample evaluation.

Event Description

Second degree burns the size of a silver dollar and almost on the right side of the hip [burns second degree] , kind of a blister after it has burst [blister rupture] , laying on her back on the bed on and off during the 5 hours of heatwrap usage/ did not check her skin under the wrap during usage [intentional device misuse] , laying on her back on the bed on and off during the 5 hours of heatwrap usage/ did not check her skin under the wrap during usage [device use error] , was hotter than other devices used in the past [device issue] ,.Case narrative:this is a spontaneous report from a contactable consumer.A (b)(6) female patient started to use thermacare heatwrap (thermacare lower back & hip) (device lot number: n15776, expiration date: apr2021) from (b)(6) 2016 for back pain.Medical history included blood pressure abnormal from an unknown date and unknown if ongoing and unspecified back surgeries in 2004 and 2006.Concomitant medication included ongoing labetalol at 200 mg, 2x/day oral for blood pressure, ongoing lovastatin at 200 mg, 1x/day oral for blood pressure and ongoing oxycodone at 30 mg tablet up to 5 times per day as needed for back pain from 2004.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.The patient reported she applied the heatwrap for 5 hours and removed it before she went to bed as it started hurting and getting too hot, on friday night, (b)(6) 2016.It was at this time she discovered a second degree burn.She stated she noticed this wrap was hotter compared to others used in the past.The patient stated she was laying on her back on the bed on and off during the 5 hours of heatwrap usage.She used a towel between the heatwrap and her skin.The patient did not check her skin under the wrap during usage.The burn was described as the size of a silver dollar and almost on the right side of the hip.Per the patient's husband, the area was red, with kind of a blister after it has burst.She went to the emergency room on saturday, (b)(6) 2016 where she was treated with antibiotic lotion and an oral antibiotic.The patient was scheduled to follow-up with her primary doctor in one week's time.The patient assessed her skin tone as medium (neither light nor dark, tans very easily).She is currently under the care of a physician for blood pressure and for follow-up on pain medication for back.The patient denied having sensitive skin and denied any abnormal skin conditions.The patient read the usage instructions for the heatwrap prior to use.She did not engage in exercise while using the heatwrap.The patient previously used other heat products for pain relief, reported as aleve tens unit without any adverse effect.Action taken with the suspect product was permanently withdrawn on (b)(6) 2016.Therapeutic measures taken included antibiotic lotion (mupirocin 2% ointment, 22 gm, applied 3 times daily for 10 days) and an antibiotic by mouth (cephalexin 500 mg, 3 times daily for 7 days).Clinical outcome of the events second degree burns and blister burst was not resolved, other events outcome was unknown.Product quality investigational results included: investigation summary: the root cause category is non assignable (complaint not confirmed).The plant has reviewed this batch from a manufacturing and technical 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.Consumer alleges the product is too hot.The cause of the alleged wrap being too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.This investigation was reopened to add the return sample evaluation results.The wrap returned was not the wrap the consumer complained about (the other wrap that came in the same box).The sample did not provide any additional information as to why the consumer felt the wrap "was hotter compared to others used in the past".The investigation summary nor the root cause changed as a result of the returned sample evaluation.Additional information has been requested and will be provided as it becomes available.Follow-up (05jan2017): new information received from product quality complaint group includes investigation results.Follow-up (03mar2017): new information received from product quality complaint group includes investigation results.This investigation was reopened to add the return sample evaluation results.Company clinical evaluation comment: based on the available information, the events of second degree burns and blister rupture after using heatwrap with device issue, and device use error as described in this case is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device., comment: based on the available information, the events of second degree burns and blister rupture after using heatwrap with device issue, and device use error as described in this case is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.

• 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
• Manufacturer Contact: b green ; 235 e42nd street; new york, NY 10017
• MDR Report Key: 6131495
• MDR Text Key: 61019930
• Report Number: 1066015-2016-00155
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/21/2016

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2021
• Device Lot Number: N15776
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/29/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/10/2017; 03/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: LABETALOL; LOVASTATIN; OXYCODONE
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 90