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

Lot Number S23837;AD3849

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

Event verbatim [preferred term] uses the back pain therapy wrap on his knee [device use issue].Case narrative: this is a spontaneous report from a contactable consumer reported for her husband.A (b)(6) year old male patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number s23837, device lot number ad3849, lot expiry oct2012, for 3 years (since approximately 2016) and ongoing at as needed (prn) for arthritic pain back/knee.The reporter also provided the following lot numbers and expiration dates : 30573 3015 025 dec2021, 30573 3015 025 dec2021, 0573 3010 03 28nov oct2012, 0573 3010 02 feb2020, and 0573-3015-02.The patient's medical history was not reported.There were no concomitant therapies.The reporter was calling about the recall.The reporter stated that her husband used the back pain therapy wrap on his knee.The reporter states there was hospitalization involved and the patient received treatment for the event.The action taken in response to the event for thermacare heatwrap was unknown.The event was ongoing (not recovered).Additional information has been requested and will be provided as it becomes available.Follow-up (20jun2019): follow-up attempts are completed.No further information is expected.Follow-up (14jun2019): new information from a contactable consumer includes: patient information (age), product information (additional lot numbers and expiration dates, start date, frequency, indication), concomitant medications (none), event information (hospitalization and treatment information, outcome).This follow-up upgrades the case to a reportable medical device report.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the available information, the event "uses the back pain therapy wrap on his knee" is serious because of requiring hospital admission.No adverse event was associated with the use of the device.The event was assessed associated with the use of the device., comment: based on the available information, the event "uses the back pain therapy wrap on his knee" is serious because of requiring hospital admission.No adverse event was associated with the use of the device.The event was assessed associated with the use of the device.

Event Description

Event verbatim [preferred term] uses the back pain therapy wrap on his knee [device use issue] ,.Case narrative:this is a spontaneous report from a contactable consumer reported for her husband.A 63-year-old male patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number s23837, device lot number ad3849, expiry date 29feb2020, 31oct2021 (previously reported as oct2012), since approximately 2016 and ongoing for 3 years at as needed for arthritic pain back/knee.The reporter also provided the following lot numbers and expiration dates: 30573 3015 025 dec2021, 30573 3015 025 dec2021, 0573 3010 03 28nov oct2012, 0573 3010 02 feb2020, and 0573-3015-02.The patient's medical history was not reported.There were no concomitant therapies.The reporter was calling about the recall.The reporter stated that her husband used the back pain therapy wrap on his knee from unknown date.The reporter stated there was hospitalization involved and the patient received treatment for the event.The action taken in response to the event for thermacare heatwrap was unknown.The outcome of the event was not recovered.Additional information has been requested and will be provided as it becomes available.Follow-up (20jun2019): follow-up attempts are completed.No further information is expected.Follow-up (14jun2019): new information from a contactable consumer includes: patient information (age), product information (additional lot numbers and expiration dates, start date, frequency, indication), concomitant medications (none), event information (hospitalization and treatment information, outcome).This follow-up upgrades the case to a reportable medical device report.Follow-up attempts are completed.No further information is expected.Follow up (09jul2019): this follow-up contains no new medically significant information.Follow up (11jul2019): this follow-up contains no new medically significant information.Follow-up attempts are completed.No further information is expected.Follow-up (07aug2019): new information received from a product quality complaint group included update expiration date.Company clinical evaluation comment: based on the available information, the event "uses the back pain therapy wrap on his knee" is serious because of requiring hospital admission.The event was assessed associated with the use of the device., comment: based on the available information, the event "uses the back pain therapy wrap on his knee" is serious because of requiring hospital admission.The event was assessed associated with the use of the device.

Event Description

Event verbatim [preferred term] uses the back pain therapy wrap on his knee [device use issue] ,.Case narrative:this is a spontaneous report from a contactable consumer reported for her husband.A 63-year-old male patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number s23837, device lot number ad3849, expiry date 29feb2020, 31oct2021 (previously reported as oct2012), since approximately 2016 and ongoing for 3 years at as needed for arthritic pain back/knee.The reporter also provided the following lot numbers and expiration dates: 30573 3015 025 dec2021, 30573 3015 025 dec2021, 0573 3010 03 28nov oct2012, 0573 3010 02 feb2020, and 0573-3015-02.The patient's medical history was not reported.There were no concomitant therapies.The reporter was calling about the recall.The reporter stated that her husband used the back pain therapy wrap on his knee from unknown date.The reporter stated there was hospitalization involved and the patient received treatment for the event.The action taken in response to the event for thermacare heatwrap was unknown.The outcome of the event was not recovered.Product investigation results were as follows: the root cause category is non assignable (complaint not confirmed as quality defect).After a review of the batch thermal records, thermal results all met product release criteria.The consumer stated the lower back hip wrap was worn on the knee.The cause of the hospitalization is inconclusive since it is not clear what cause the hospitalization.The 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 any avoid the risks.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.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.Thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6°c-41.6°c) per small back printed, spec-23452, effective: 28nov2016.There were no wrap attribute or variable defects recorded for the batch.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch.Severity of harm: s3.Additional information has been requested and will be provided as it becomes available.Follow-up (20jun2019): follow-up attempts are completed.No further information is expected.Follow-up (14jun2019): new information from a contactable consumer includes: patient information (age), product information (additional lot numbers and expiration dates, start date, frequency, indication), concomitant medications (none), event information (hospitalization and treatment information, outcome).This follow-up upgrades the case to a reportable medical device report.Follow-up attempts are completed.No further information is expected.Follow up (09jul2019): this follow-up contains no new medically significant information.Follow up (11jul2019): this follow-up contains no new medically significant information.Follow-up attempts are completed.No further information is expected.Follow-up (07aug2019): new information received from a product quality complaint group included update expiration date.Follow-up (03oct2019): follow-up attempts are completed.No further information is expected.Follow-up (28aug2019): new information received from the product quality complaint group includes product investigation summary results.Company clinical evaluation comment: based on the available information, the event "uses the back pain therapy wrap on his knee" is serious because of requiring hospital admission.The event was assessed associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the available information, the event "uses the back pain therapy wrap on his knee" is serious because of requiring hospital admission.The event was assessed associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.

Manufacturer Narrative

The root cause category is non assignable (complaint not confirmed as quality defect).After a review of the batch thermal records, thermal results all met product release criteria.The consumer stated the lower back hip wrap was worn on the knee.The cause of the hospitalization is inconclusive since it is not clear what cause the hospitalization.The 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 any avoid the risks.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.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.Thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6°c-41.6°c) per small back printed, spec-23452, effective: (b)(6)2016.There were no wrap attribute or variable defects recorded for the batch.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch.Severity of harm: s3.

• 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
• MDR Report Key: 8745303
• MDR Text Key: 149921399
• Report Number: 1066015-2019-00197
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 05/06/2019

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2020
• Device Lot Number: S23837;AD3849
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/28/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/27/2019; 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR