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

Lot Number N31954; 6336EA

Device Problems Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)

Patient Problems Irritation (1941); Pain (1994); Rash (2033); Burn, Thermal (2530)

Event Date 03/01/2017

Event Type  Injury  

Manufacturer Narrative

Investigation summary: the root cause category is non-assignable (complaint not confirmed).Our 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.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The cause of the alleged lack of effect is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Investigation summary: the root cause category is non-assignable (complaint not confirmed).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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.

Event Description

May have burned her back/painful red, raised rash with irritated skin [thermal burn], applying the heatwrap, then laid down and woke up the next day [intentional device misuse].Case narrative:this is a spontaneous report from a contactable consumer.A (b)(6)-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip) (device lot number: n31954, also reported as 6336ea, expiration date: mar2019) from (b)(6) 2017 for back pain.Medical history included ongoing syrinx (diagnosed about 6 years ago), severe headaches, migraines and difficulty breathing.The patient's concomitant medications were not reported.The patient previously took ibuprofen and experienced anaphylactic shock; excedrin and experienced an unspecified adverse event; and an unspecified medication (something like an epi pen) and experienced difficulty breathing.On (b)(6) 2017, the patient reported applying the heatwrap for 8 hours, experienced irritation, then laid down and woke up the next day and put another heatwrap on.On (b)(6) 2017, the patient reported she experienced a painful red, raised rash with irritated skin all over where she had applied the heatwrap in the area on the back concentrated where the heat pockets were with no blisters.She thought at first it may have burned her back in (b)(6) 2017 but she had no blister, it was just irritated red and raised.Not pimply but blotchy and red.Very irritated.She stated it wasn't the heat bothering her, but something in the product that was bothering her.The rash did not spread beyond all over her back, maybe a little to the perimeter.The patient did not use any lotions or salves in combination with the heatwraps.The patient read and understood the instructions prior to heatwrap use.The patient further reported she broke out in a rash while using the product.The patient also mentioned that this was not the first time she had an adverse reaction to a medication.Nine years ago she had a bad reaction that sent her to the hospital.There was something in these products that sent her to the hospital.Action taken with the suspect product was permanently withdrawn on (b)(6) 2017.Therapeutic measures taken included a shower to clean the area and left it dry, did not rub it or put any cream on it.Clinical outcome of the events was resolved by (b)(6) 2017.According to the product quality complaint group on 18may2017: investigation summary: the root cause category is non-assignable (complaint not confirmed).Our 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.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The cause of the alleged lack of effect is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.According to the product quality complaint group on 26may2017: investigation summary: the root cause category is non-assignable (complaint not confirmed).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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Follow-up (07apr2017): new information received from a contactable consumer included product data (additional lot #), reaction data (onset date of events and date of recovery).Follow-up (25apr2017): new information received from the same contactable consumer includes: event details (she broke out in a rash while using the product).Follow- up (18may2017): new information received from the product quality complaint group included investigational results.Follow-up attempts are completed.No further information is expected.Follow-up (26may2017): new information received from the product quality complaint group included investigational results.Follow-up attempts are completed.No further information is expected.Follow-up (01jun2017): new information received from the same contactable consumer includes: past drug information.Follow-up (05apr2017): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment: based on the information provided, the events thermal burn and intentional device misuse as described are considered serious bodily injury 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.Comment: based on the information provided, the events thermal burn and intentional device misuse as described are considered serious bodily injury 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.

• 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: stella pietrafesa ; 235 e42nd street; new york, NY 10017
• MDR Report Key: 9259822
• MDR Text Key: 184873800
• Report Number: 1066015-2019-00395
• 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
• Report Date: 04/05/2017

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
• Device Expiration Date: 03/01/2019
• Device Lot Number: N31954; 6336EA
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2019
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 54