MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAP; DISPOSABLE PACK, HOT

Device Problems Loss of or Failure to Bond (1068); Excessive Heating (4030)

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

Event Type  malfunction  

Event Description

Coat it didn't stick well and got to hot! we tried over clothes and don't stick well either [device issue].Narrative: this is a spontaneous report from a from a legacy pfizer sponsored program ((b)(6) review & response program) transitioned into the pfizer and glaxosmithkline joint venture.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare heatwrap), via an unspecified route of administration from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.According to the reporter, "coat it didn't stick well and got to hot! we tried over clothes and don't stick well either." the event occurred on an unspecified date.The action taken and event outcome were not reported.Additional information has been requested and will be provided as it becomes available.

Manufacturer Narrative

Severity of harm was provided as s3.This investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.The root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number, 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.The 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.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.Site sample status was not received.Additional investigational results from the product quality complaint for complaint sub-class: adhesion/fastening defect, severity of harm was s1, this investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.The root cause category is non-assignable (complaint not confirmed as a quality defect).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 adhesion/fastening defect.The 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.Root cause /capa: process related was no.Final confirmation status was not confirmed.Lot trend assessment and rationale: a lot trend was not performed as the lot number is unknown.

Event Description

Event verbatim [preferred term] coat it didn't stick well and got to hot! we tried over clothes and don't stick well either [device issue], narrative: this is a spontaneous report from a legacy pfizer sponsored program amazon vine review & response program transitioned into the pfizer and glaxosmithkline joint venture from a non-contactable consumer.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare heatwrap), via an unspecified route of administration from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.According to the reporter, "coat it didn't stick well and got to hot! we tried over clothes and don't stick well either." the event occurred on an unspecified date.The action taken and event outcome were unknown.According to the product quality complaint group: severity of harm was provided as s3.This investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.The root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number, 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.The 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.Lot trend assessment and rationale: a lot trend was not performed as the lot number is unknown.Site sample status was not received.Additional investigational results from the product quality complaint for complaint sub-class: adhesion/fastening defect, severity of harm was s1, this investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.The root cause category is non-assignable (complaint not confirmed as a quality defect).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 adhesion/fastening defect.The 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.Root cause /capa: process related was no.Final confirmation status was not confirmed.Lot trend assessment and rationale: a lot trend was not performed as the lot number is unknown.Follow-up (02aug2020): new information received from the product quality complaint group included investigational results.No follow-up attempts are needed.No further information is expected.Follow-up (17aug2020): new information received from the product quality complaint group includes investigational results for complaint sub-class: adhesion/fastening defect.No follow-up attempts are needed.No further information is expected.

Event Description

Event verbatim [preferred term].Coat it didn't stick well and got to hot! we tried over clothes and don't stick well either [device issue], , narrative: this is a spontaneous report from a legacy pfizer sponsored program (amazon vine review & response program) transitioned into the pfizer and glaxosmithkline joint venture from a non-contactable consumer.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare heatwrap), via an unspecified route of administration from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.According to the reporter, "coat it didn't stick well and got to hot! we tried over clothes and don't stick well either." the event occurred on an unspecified date.The action taken and event outcome were unknown.According to the product quality complaint group: severity of harm was provided as s3.This investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.The root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number, 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.The 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.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.Site sample status was not received.Follow-up (02aug2020): new information received from the product quality complaint group included investigational results.No follow-up attempts are needed.No further information is expected.

Manufacturer Narrative

Severity of harm was provided as s3.This investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.The root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number, 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.The 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.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.Site sample status was not received.

• Brand Name: THERMACARE HEATWRAP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 10227922
• MDR Text Key: 203492586
• Report Number: 1066015-2020-00138
• 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: 06/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1