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

Lot Number CM0813

Device Problems Use of Device Problem (1670); Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

2 out of the 3 ripped.I had to use a safety pin to put them together.[intentional device misuse].2 out of the 3 ripped.I had to use a safety pin to put them together.[device breakage].Narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare heatwrap) lot is cm0813, expiration date sep2022, via an unspecified route of administration from an unspecified date to an unspecified date (using it for years) for cramps in my stomach.The patient medical history and concomitant medications were not reported.The consumer reported there are 3 of them in the box.2 out of the 3 ripped.I had to use a safety pin to put them together on an unspecified date.The action taken in response to the event for thermacare heatwrap was unknown.The outcome of the event was unknown.Additional information has been requested and will be provided as it becomes available.

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 product release criteria.Consumer reports that the wrap may have caused " i had to use a safety pin to put them together." the cause of the consumer statement "i had to use a safety pin to put them together".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, following all safety and use information as provided with the wrap to avoid all risk.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.

Event Description

Event verbatim [preferred term] had to use a safety pin to put them together.[intentional device misuse].Narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (robax lower back & hip heatwrap) lot is cm0813, expiration date sep2022, via an unspecified route of administration from an unspecified date to an unspecified date (using it for years).The patient medical history included cramps in stomach.Concomitant medications were not reported.The consumer reported there are 3 of them in the box.2 out of the 3 ripped.She had to use a safety pin to put them together on an unspecified date.The action taken in response to the event for thermacare heatwrap was unknown.The outcome of the event was unknown.According to product quality group: conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).The sample is not available from consumer for evaluation, the complaint can not be 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.The product quality for the batch is not impacted by this complaint.According to product quality group: 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 that the wrap may have caused " i had to use a safety pin to put them together." the cause of the consumer statement "i had to use a safety pin to put them together".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, following all safety and use information as provided with the wrap to avoid all risk.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 (27jan2021): new information received from product quality group includes investigation results; suspect was recoded to robax lower back & hip heatwrap per pqc results, this follow-up report is being submitted to amend previously reported information: "cramps in my stomach" was removed from indication and captured as med history.Follow-up (10feb2021): new information received from product quality complaint group includes investigation results.No follow-up attempts required.No further information expected.Amendment: this follow-up report is being submitted to amend previously reported information: the event 'device breakage' was deleted.The case was down-graded to non-reportable medical device report.

Manufacturer Narrative

The root cause category is non-assignable (complaint not confirmed as a quality defect).The sample is not available from consumer for evaluation, the complaint can not be 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.The product quality for the batch is not impacted by this complaint.

Event Description

Event verbatim [preferred term].2 out of the 3 ripped.I had to use a safety pin to put them together.[device breakage], 2 out of the 3 ripped.I had to use a safety pin to put them together.[intentional device misuse], , narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (robax lower back & hip heatwrap) lot is cm0813, expiration date sep2022, via an unspecified route of administration from an unspecified date to an unspecified date (using it for years).The patient medical history included cramps in stomach.Concomitant medications were not reported.The consumer reported there are 3 of them in the box.2 out of the 3 ripped.She had to use a safety pin to put them together on an unspecified date.The action taken in response to the event for thermacare heatwrap was unknown.The outcome of the event was unknown.According to product quality group: conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).The sample is not available from consumer for evaluation, the complaint can not be 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.The product quality for the batch is not impacted by this complaint.Additional information has been requested and will be provided as it becomes available.Follow-up (27jan2021): new information received from product quality group includes investigation results; suspect was recoded to robax lower back & hip heatwrap per pqc results, this follow-up report is being submitted to amend previously reported information: "cramps in my stomach" was removed from indication and captured as med history.

Event Description

Event verbatim [preferred term] 2 out of the 3 ripped.I had to use a safety pin to put them together.[device breakage], 2 out of the 3 ripped.I had to use a safety pin to put them together.[intentional device misuse], , narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (robax lower back & hip heatwrap) lot is cm0813, expiration date sep2022, via an unspecified route of administration from an unspecified date to an unspecified date (using it for years).The patient medical history included cramps in stomach.Concomitant medications were not reported.The consumer reported there are 3 of them in the box.2 out of the 3 ripped.She had to use a safety pin to put them together on an unspecified date.The action taken in response to the event for thermacare heatwrap was unknown.The outcome of the event was unknown.According to product quality group: conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).The sample is not available from consumer for evaluation, the complaint can not be 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.The product quality for the batch is not impacted by this complaint.According to product quality group: 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 that the wrap may have caused " i had to use a safety pin to put them together." the cause of the consumer statement "i had to use a safety pin to put them together".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, following all safety and use information as provided with the wrap to avoid all risk.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 (27jan2021): new information received from product quality group includes investigation results; suspect was recoded to robax lower back & hip heatwrap per pqc results, this follow-up report is being submitted to amend previously reported information: "cramps in my stomach" was removed from indication and captured as med history.Follow-up (10feb2021): new information received from product quality complaint group includes investigation results.No follow-up attempts required.No further information expected.

Manufacturer Narrative

The root cause category is non-assignable (complaint not confirmed as a quality defect).The sample is not available from consumer for evaluation, the complaint can not be 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.The product quality for the batch is not impacted by this complaint.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 that the wrap may have caused " i had to use a safety pin to put them together." the cause of the consumer statement "i had to use a safety pin to put them together".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, following all safety and use information as provided with the wrap to avoid all risk.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 GA L5R4B 2; CA L5R4B2
• MDR Report Key: 11204445
• MDR Text Key: 230990470
• Report Number: 1066015-2021-00011
• 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,Followup,Followup
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/01/2022
• Device Lot Number: CM0813
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1