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

Lot Number AD53848; W91242

Device Problems Overheating of Device (1437); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The root cause for never worked, too cool, did not last long enough and squeeze tube complaint sub classless is due to a pouch (primary packaging) that did not seal completely (open pouch).An open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heating up.An open pouch is caused by equipment; specifically ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.The severity of pouch leaks is s1 no harm to customer.This investigation was conducted for an unknown lot number of lower back/hip (lbh).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.There was an increase in complaints received in (b)(6) 2019 for wrap/patch/pad too hot due to the recall of (b)(6) 2019 for lbh batches s97473, s00639, s23902, w37940.Investigation pr3938189 was completed for the trend of too hot for lbh.There was no device malfunction identified for batches w59249, ad3849, w91244.A trend for the subclass of adverse event safety for investigation with product type lbh products was not identified.This investigation was conducted for an unknown lot number lower back/hip (lbh) product.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 product quality complaints group provided updated results: the root cause categor.

Event Description

Got too hot immediately and she was afraid of getting a burn [device issue] , once she wore a wrap all day and then put on another one right after [device use error] ,.Case narrative:this is a spontaneous report from a contactable consumer.This (b)(6) year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip) lot number: ad53848, expiry date: oct2021; lot number: w91242, expiry date: aug2021, via an unspecified route of administration, from an unspecified date, at unknown dose for bulging lumbar discs and back pain.Medical history and concomitant medications were not reported.The patient used the thermacare heat wraps, for her 3 bulging lumbar discs and 2 seriously herniated ones, so she was in pain all the time, and was waiting on decisions what to do and she couldn't live without the thermacare heat wraps.She used them almost every day and took care of her grandson and when he was there she really needed them.The patient had two boxes that were duds, they didn't heat well.She stated she wore the wraps about 5 days out of 7.She mentioned that once she wore a wrap all day and then put on another one right after.The second one she had to take off soon because it got too hot immediately and she was afraid of getting a burn.She never had tried wearing one after another again after that.The action taken with thermacare heatwrap and the outcome of the events was unknown.According to product quality complaints group: the root cause for never worked, too cool, did not last long enough and squeeze tube complaint sub classless is due to a pouch (primary packaging) that did not seal completely (open pouch).An open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heating up.An open pouch is caused by equipment; specifically ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.The severity of pouch leaks is s1 no harm to customer.This investigation was conducted for an unknown lot number of lower back/hip (lbh).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.There was an increase in complaints received in (b)(6) 2019 for wrap/patch/pad too hot due to the recall of (b)(6) 2019 for lbh batches s97473, s00639, s23902, w37940.Investigation pr3938189 was completed for the trend of too hot for lbh.There was no device malfunction identified for batches w59249, ad3849, w91244.A trend for the subclass of adverse event safety for investigation with product type lbh products was not identified.This investigation was conducted for an unknown lot number lower back/hip (lbh) product.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 product quality complaints group provided updated results on (b)(6) 2020: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap, " got too hot immediately and she was afraid of getting a burn." the cause of the consumer stating the wrap getting hot immediately 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.On the basis of this evaluation, a trend does not exist for this batch.Site sample status: not received follow-up (b)(6)2019): new information received from the contactable consumer includes: demographic data (age added); suspect drug data (indication added) and patient comments.Follow-up (b)(6) 2019): new information received from a product quality complaints group included: investigation results.Follow-up (b)(6) 2019): follow-up attempts are completed.No further information is expected.Follow-up (b)(6) 2019): new information received from a product quality complaints group included: investigation results.Follow-up (b)(6) 2019): new information from product quality complaints includes: severity rating (s3) and investigation results for subclass adverse event safety request for investigation.Follow-up (b)(6) 2020): new information received from a product quality complaint group includes updated investigation results; event data (got too hot added).Follow-up attempts are completed.No further information is expected., comment: based on available information, the patient reported device issue represents a potential device malfunction.No adverse event was associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.The event device use error was assessed as non-serious.A causal relationship between the device and the events cannot be ruled out.

• 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: 9637307
• MDR Text Key: 191402743
• Report Number: 1066015-2020-00016
• 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: 05/22/2019

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: 08/01/2021
• Device Lot Number: AD53848; W91242
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2020
• 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 Age: 65 YR