MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE NECK, SHOULDER & WRIST; DISPOSABLE PACK, HOT

Lot Number AJ3018

Device Problems Insufficient Heating (1287); Excessive Heating (4030)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Event verbatim [preferred term]: 2 did not get warm at all and 1 worked fine, 1 heatwrap got too hot [device issue].Narrative: this is a spontaneous report from a contactable pharmacist.This is a report based on information received by pfizer from (b)(4), license party for thermacare heatwraps.A (b)(6) year-old female patient started to use thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number aj3018) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient stated 4 patches out of the pack were used, 2 did not get warm at all and 1 worked fine.1 heatwrap got too hot and the patient had to remove it.Action taken with the suspect product was unknown.Clinical outcome of the event was unknown.Additional information has been requested and will be provided as it becomes available.

Event Description

Event verbatim [preferred term] 2 did not get warm at all and 1 worked fine, 1 heatwrap got too hot [device issue], , narrative: this is a spontaneous report from a contactable pharmacist.This is a report based on information received by pfizer from (b)(6), license party for thermacare heatwraps.A 38-year-old female patient started to use thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number aj3018) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient stated 4 patches out of the pack were used, 2 did not get warm at all and 1 worked fine.1 heatwrap got too hot and the patient had to remove it.Action taken with the suspect product was unknown.Clinical outcome of the event was unknown.Additional information received from product quality complaint (pqc) group included investigation results.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 the product release criteria.The consumer reports that the heatwrap "got too hot".Review of the records does not provide evidence to support a defective product.The product effect may vary with each individual.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 product quality for the batch is not impacted by this complaint.Additional information received from product quality complaint (pqc) group included investigation results.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.Follow-up (04mar2021 and 05mar2021): new information received from product quality complaints (pqc) group included: product quality investigation results.No follow-up attempts are needed/possible.No further information is expected.

Manufacturer Narrative

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 the product release criteria.The consumer reports that the heatwrap "got too hot".Review of the records does not provide evidence to support a defective product.The product effect may vary with each individual.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 product quality for the batch is not impacted by this complaint.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.

• Brand Name: THERMACARE NECK, SHOULDER & WRIST
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 11438572
• MDR Text Key: 262950326
• Report Number: 1066015-2021-00033
• 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: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: AJ3018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/08/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 38 YR