MAUDE Adverse Event Report: PFIZER CONSUMER HEALTHCARE (CANADA) ROBAX LOWER BACK & HIP HEATWRAP; DISPOSABLE PACK, HOT

Catalog Number 0 62107 33630 7

Device Problem Material Deformation (2976)

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

Event Type  malfunction  

Event Description

Wraps was torn [device leakage].Narrative: this is a spontaneous report from a contactable consumer.This female consumer of unknown age started to receive thermacare heatwrap (robax lower back & hip heatwrap) lot number dg0112, expiration date nov2022, catalog number 0 62107 33630 7, via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for an unspecified indication.Medical history and concomitant medications were not reported.Consumer bought a robax for lower back and one of the wraps was torn.The first one was fine the second one was torn.There were 3 in a box.The action taken in response to the event of the product was unknown.The 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]: wraps was torn [device breakage], narrative: this is a spontaneous report from a contactable consumer.This female consumer of unknown age started to receive thermacare heatwrap (robax lower back & hip heatwrap)lot number dg0112, expiration date nov2022, catalog number 0 62107 33630 7, via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for an unspecified indication.Medical history and concomitant medications were not reported.Consumer bought a robax for lower back and one of the wraps was torn.The first one was fine the second one was torn.There were 3 in a box.The action taken in response to the event of the product was unknown.The outcome of the event was unknown.According to product quality complaint, batch dg0112 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.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/negligible-minor received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Conclusion: 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 " one of the wraps was torn" the cause of the consumer statement "one of the wraps was torn" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device.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.Follow up (12jan2021): new information received from product quality complaint included: investigation results.The event "wraps was torn" was recoded from device leakage to device breakage.

Manufacturer Narrative

Batch dg0112 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.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/negligible-minor received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Conclusion: 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 " one of the wraps was torn" the cause of the consumer statement "one of the wraps was torn" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device.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.

• Brand Name: ROBAX LOWER BACK & HIP HEATWRAP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTHCARE (CANADA); (a division of pfizer canada i; nc.) 450-55 standish court; mississauga L5R4B 2; CA L5R4B2
• MDR Report Key: 11013220
• MDR Text Key: 251295033
• Report Number: 1066015-2020-00203
• 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,foreign
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2022
• Device Catalogue Number: 0 62107 33630 7
• Device Lot Number: DG0112
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1