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

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

Patient Problem Swelling/ Edema (4577)

Event Type  Injury  

Event Description

Foot, ankle and toes got swollen [peripheral swelling], foot, ankle and toes got swollen [joint swelling], , narrative: this is a spontaneous report from a non-contactable consumer.This consumer of unspecified age and gender started to use thermacare heatwrap (trade name unspecified) on an unknown date for an unknown indication.Relevant medical history and concomitant medications were not reported.The consumer put thermacare on ankle and then foot, ankle and toes got swollen.The action taken with thermacare heatwrap and outcome of the event were unknown.The patient asked "what to do to cure this".No follow-up attempts are possible.No further information is expected.

Event Description

Event verbatim [preferred term].Foot, ankle and toes got swollen [peripheral swelling], foot, ankle and toes got swollen [joint swelling], , narrative: this is a spontaneous report from a non-contactable consumer.A patient of unspecified age and gender used thermacare heatwrap (thermacare heatwrap, trade name unspecified) on an unknown date for an unknown indication.Relevant medical history and concomitant medications were not reported.The patient put thermacare on and then foot, ankle and toes got swollen.The patient stated "all i need you to tell me is what i can do to cure this." action taken with the suspect product was unknown.Clinical outcomes of the events were 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).There was limited device-specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number or a return sample, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid all risks.There is not a product quality-related trend identified for the subclass adverse event/serious/unknown.The manufacturing operations employ quality control procedures, which include in-process testing, thermal testing, and visual inspection, to ensure the quality of the packaged product.Reasonably suggest device malfunction?: no.Severity of harm: n/a.Site sample status: not received.Follow-up (03feb2021): new information received from product quality complaints (pqc) group included: product quality investigation results.No follow-up attempts are possible.No further information is expected.Follow-up (01mar2021): new information from product quality complaints includes: updated reportability assessment.The case is downgraded to not reportable.No follow-up attempts are possible.No further information is expected.

Manufacturer Narrative

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 or a return sample, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid all risks.There is not a product quality-related trend identified for the subclass adverse event/serious/unknown.The manufacturing operations employ quality control procedures, which include in-process testing, thermal testing, and visual inspection, to ensure the quality of the packaged product.Reasonably suggest device malfunction?: no.Severity of harm: n/a.Site sample status: not received.

Manufacturer Narrative

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 or a return sample, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid all risks.There is not a product quality-related trend identified for the subclass adverse event/serious/unknown.The manufacturing operations employ quality control procedures, which include in-process testing, thermal testing, and visual inspection, to ensure the quality of the packaged product.Reasonably suggest device malfunction?: no.Severity of harm: site sample status: not received.

Event Description

Event verbatim [preferred term], foot, ankle and toes got swollen [peripheral swelling], foot, ankle and toes got swollen [joint swelling], , narrative: this is a spontaneous report from a non-contactable consumer.A patient of unspecified age and gender used thermacare heatwrap (thermacare heatwrap, trade name unspecified) on an unknown date for an unknown indication.Relevant medical history and concomitant medications were not reported.The patient put thermacare on and then foot, ankle and toes got swollen.The patient stated "all i need you to tell me is what i can do to cure this." action taken with the suspect product was unknown.Clinical outcomes of the events were 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).There was limited device-specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number or a return sample, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid all risks.There is not a product quality-related trend identified for the subclass adverse event/serious/unknown.The manufacturing operations employ quality control procedures, which include in-process testing, thermal testing, and visual inspection, to ensure the quality of the packaged product.Reasonably suggest device malfunction?: no.Severity of harm: n/a.Site sample status: not received follow-up (03feb2021): new information received from product quality complaints (pqc) group included: product quality investigation results.No follow-up attempts are possible.No further information is expected.

• 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: 11245956
• MDR Text Key: 229296218
• Report Number: 1066015-2021-00012
• 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: 01/14/2021

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?: Yes
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2021
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/17/2021; 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention