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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems High Blood Pressure/ Hypertension (1908); Pain (1994); Tachycardia (2095); Brain Injury (2219); Increased Respiratory Rate (2486); Partial thickness (Second Degree) Burn (2694)

Event Date 12/13/2015

Event Type  Injury  

Event Description

Burns second degree/ burn at lumbar region/ large lesions/ blisters [burns second degree], applies lumbar band/ wears a dry suit diving [intentional device misuse].Case description: this is a spontaneous report from a contactable physician received by pfizer via a lawyer.A (b)(6) male patient of an unspecified ethnicity started to receive thermacare heatwrap (thermacare lower back & hip), via an unspecified route of administration on (b)(6) 2015 for lower back pain.Medical history included hypertension treated with aprovel.The patient's concomitant medications were not reported.On (b)(6) 2015, the patient applied lumbar band of thermacare, then wore a dry suit and went diving.After 15 minutes of diving and 5 hours from the application of thermacare, the patient complains in correspondence of the heating lumbar band, a sudden burning and unbearable pain.The patient tries to rise to the surface as quickly as possible, but he must comply with decompression in order to avoid serious damage.As soon as he arrives at the dive center, the patient removes the band of thermacare, which is perfectly intact and dry, but on his back in the application site there are large lesions.The patient went to the hospital, had sterile gauze applied to the burn site, and suggested to visit another specialized center due the presence of burn.At another emergency room of another hospital on (b)(6) 2015, the patient was assessed: alert, eupneic, currently controlled pain, pain value 5, heart rate 90, respiratory rate 16, glasgow coma scale 15, and blood pressure 150/80.The summary of general plastic surgery visit reports: second-degree burn to the back lumbar region and blisters.Therapeutic measures taken in response to event included application of betadine, gauze and tachipirina 1000mg 1 tablet every 8 hours for pain.The patient left the hospital on the same day, (b)(6) 2015 and returned on (b)(6) 2015 for treatment.The action taken in response to the event for thermacare heatwrap was permanently withdrawn on (b)(6) 2015.The outcome of the event was unknown.No follow-up attempts possible.No further information expected.

Event Description

Event verbatim [preferred term] burns second degree/ burn at lumbar region/ large lesions/ blisters [burns second degree], applies lumbar band/ wears a dry suit diving [intentional device misuse].Case narrative:this is a spontaneous report from a contactable physician received by pfizer via a lawyer.A 51-year-old male patient started to receive thermacare heatwrap (thermacare lower back & hip), via an unspecified route of administration on (b)(6) 2015 for lower back pain.Medical history included hypertension treated with irbesartan (aprovel).The patient's concomitant medications were not reported.On (b)(6) 2015, the patient applied lumbar band of thermacare, then wore a dry suit and went diving.After 15 minutes of diving and 5 hours from the application of thermacare, the patient complains in correspondence of the heating lumbar band, a sudden burning and unbearable pain on his lower back which was directly in contact with the wrap.The patient tries to rise to the surface as quickly as possible, but he must comply with decompression in order to avoid serious damage.As soon as he arrives at the dive center, the patient removes the band of thermacare, which is perfectly intact and dry, but on his back in the application site there are large lesions.The patient went to the hospital, had sterile gauze applied to the burn site, and suggested to visit another specialized center due the presence of burn.At another emergency room of another hospital on (b)(6) 2015, the patient was assessed: alert, eupneic, currently controlled pain, pain value 5, heart rate 90, respiratory rate 16, glasgow coma scale 15, and blood pressure 150/80.The summary of general plastic surgery visit reports: second-degree burn to the back lumbar region and blisters.Therapeutic measures taken in response to event included application of betadine, gauze and tachipirina 1000mg 1 tablet every 8 hours for pain.The patient left the hospital on the same day, (b)(6) 2015 and returned on (b)(6) 2015 for treatment.The action taken in response to the event for thermacare heatwrap was permanently withdrawn on (b)(6) 2015.The outcome of the event was unknown.Product quality complaints provided the following information: there was no reasonable suggestion of device malfunction.No sample was received at the site.This investigation was conducted for an unknown lot number lower back/hip (lbh) 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 wrap/patch/pad too hot.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.Final confirmation status: not confirmed.No follow-up attempts possible.No further information expected.Follow-up (17feb2020): new information received from product quality complaints includes: investigation results.No follow-up attempts needed.No further information expected.

Manufacturer Narrative

There was no reasonable suggestion of device malfunction.No sample was received at the site.This investigation was conducted for an unknown lot number lower back/hip (lbh) 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 wrap/patch/pad too hot.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.Final confirmation status: not confirmed.

• 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: 5445344
• MDR Text Key: 38632938
• Report Number: 1066015-2016-00023
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/27/2016

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?: No
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: 01/27/2016
• Initial Date FDA Received: 02/18/2016
• Supplement Dates Manufacturer Received: 01/27/2016
• Supplement Dates FDA Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR