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

Lot Number T48909

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Itching Sensation (1943); Pain (1994); Rash (2033); Fluid Discharge (2686); Partial thickness (Second Degree) Burn (2694)

Event Date 01/07/2018

Event Type  Injury  

Event Description

Event verbatim [preferred term] she has two burn spots like bubbled up blisters at two places that are leaky, kind of like you would see they are starting to going to a third place/it hurts [burns second degree], her back broke out with some kind of little rash/the rash itches really bad [rash pruritic].Case narrative: this is a spontaneous report from a contactable consumer.This (b)(6) caucasian female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number: t48909, expiration date: sep2020, from an unspecified date for pain in lower back.Medical history included diverticulosis and depression.She does not have diabetes, poor circulation, heart disease, difficulty feeling heat or pain on her skin, rheumatoid arthritis, decreased sensation, or neuropathy.Her skin tone is classified as medium.She does not have sensitive skin or abnormal skin conditions.Concomitant medications included ongoing citalopram hydrobromide (celexa) for depression, ongoing omeprazole (protonix) for diverticulosis, and ongoing estradiol (estradiol) for estrogen.She previously used thermacare 8 or 9 years ago.Consumer reported that her back broke out with some kind of little rash, and she has two burn spots like bubbled up blisters at two places that are leaky, kind of like you would see they are starting to going to a third place.She informed that it hurts.The rash itches really bad.These events occurred on (b)(6) 2018.Consumer reported that she used both wraps in the package.The first wrap didn't seem to give her any problem; the second wrap is the one that caused a problem.She used each wrap for about 4 hours, and the number of days in a row that she used thermacare was 2.She has previously used other heat products for pain relief off and on for years.She did not use thermacare while sleeping and she read the usage instructions on thermacare before she used the product.The action taken in response to the events was unknown.Therapeutic measures for the burns included silvadene cream.Event outcome 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 of "burn blisters" 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 of "burn blisters" 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.

Event Description

Event verbatim [preferred term], she has two burn spots like bubbled up blisters at two places that are leaky, kind of like you would see they are starting to going to a third place/it hurts [burns second degree], her back broke out with some kind of little rash/the rash itches really bad [rash pruritic].Narrative: this is a spontaneous report from a contactable consumer.This 47-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number: t48909, expiration date: sep2020, from an unspecified date for pain in lower back.Medical history included ongoing diverticulosis, ongoing blood oestrogen abnormal and ongoing depression.She did not have diabetes, poor circulation, heart disease, difficulty feeling heat or pain on her skin, rheumatoid arthritis, decreased sensation, or neuropathy.Her skin tone is classified as medium.She did not have sensitive skin or abnormal skin conditions.Concomitant medications included ongoing citalopram hydrobromide (celexa) for depression, ongoing omeprazole (protonix) for divericulosis, and ongoing estradiol (estradiol) for estrogen.She previously used thermacare 8 or 9 years ago.Consumer reported that her back broke out with some kind of little rash, and she has two burn spots like bubbled up blisters at two places that are leaky, kind of like you would see they are starting to going to a third place.She informed that it hurts.The rash itches really bad.These events occurred on (b)(6) 2018.Consumer reported that she used both wraps in the package.The first wrap didn't seem to give her any problem; the second wrap is the one that caused a problem.She used each wrap for about 4 hours, and the number of days in a row that she used thermacare was 2.She has previously used other heat products for pain relief off and on for years.She did not use thermacare while sleeping and she read the usage instructions on thermacare before she used the product.The action taken in response to the events was unknown.Therapeutic measures for the burns included silvadene cream.Event outcome was not resolved.According to product quality complaint group: summary of investigation: batch t48909 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).Consumer reports "two burn spots they were like bubbled up blisters and then i have a like a little rash looking like itches real bad back." the cause of the blisters and rash is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing 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.The product quality for the batch is not impacted by this complaint.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the seventh complaint for the sub class adverse event safety request for investigation received at the albany site requiring an evaluation for this batch.The previous complaints were not confirmed to have a manufacturing related root cause for the complaint of adverse event.The complaint was evaluated to identify any potential trend.On the basis of this evaluation, a trend does not exist for this batch.The sample was not received by the site.Follow-up (27feb2019): follow-up attempts are completed.No further information is expected.Follow-up (17jun2020): new information received from a product quality complaint group included: investigation results.

Manufacturer Narrative

Batch t48909 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).Consumer reports "two burn spots they were like bubbled up blisters and then i have a like a little rash looking like itches real bad back." the cause of the blisters and rash is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing 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.The product quality for the batch is not impacted by this complaint.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the seventh complaint for the sub class adverse event safety request for investigation received at the albany site requiring an evaluation for this batch.The previous complaints were not confirmed to have a manufacturing related root cause for the complaint of adverse event.The complaint was evaluated to identify any potential trend.On the basis of this evaluation, a trend does not exist for this batch.The sample was not received by the site.

• 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: 7241470
• MDR Text Key: 99032822
• Report Number: 1066015-2018-00009
• 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
• Report Date: 01/09/2018

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
• Device Expiration Date: 09/01/2020
• Device Lot Number: T48909
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CELEXA; CELEXA [DOSAGE FORM:]; ESTRADIOL; ESTRADIOL [DOSAGE FORM:]; PROTONIX; PROTONIX [DOSAGE FORM:]; CELEXA; ESTRADIOL; PROTONIX
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 90