MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE NECK, SHOULDER & WRIST; DISPOSABLE PACK, HOT

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

Patient Problem Burn, Thermal (2530)

Event Date 11/23/2015

Event Type  Injury  

Event Description

It had burned her shoulder and it took the skin right off [thermal burn].It had burned her shoulder and it took the skin right off [skin exfoliation].Case description: this is a spontaneous report from a contactable consumer or other non hcp.A female patient of an unspecified age and ethnicity started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On (b)(6) 2015, the patient reported she had the heatwrap only for 8 hours but it had burned her left shoulder.And it took the skin right off.Action taken with the suspect product was unknown.Clinical outcome of the event was unknown.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment based on the information provided, the events thermal burn and skin exfoliation as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events thermal burn and skin exfoliation as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.

Manufacturer Narrative

Root cause /capa: process related was no.Final confirmation status was not confirmed.Site sample status was not received.This investigation was conducted for an unknown lot number neck/shoulder/wrist (nsw) 8hr product.There is no device history record (dhr) reviewed for an unknown batch number.A lot trend was not performed.The lot number is unknown.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 adverse event safety request for investigation.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.

Event Description

Event verbatim [preferred term].It had burned her shoulder and it took the skin right off [thermal burn], it had burned her shoulder and it took the skin right off [skin exfoliation].Narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On (b)(6) 2015, the patient reported she had the heatwrap only for 8 hours but it had burned her left shoulder and it took the skin right off.Action taken with the suspect product was unknown.Clinical outcome of the event was unknown.According to product quality complaints group, reasonably suggest device malfunction was no.Severity of harm was not applicable.Root cause /capa: process related was no.Final confirmation status was not confirmed.Site sample status was not received.This investigation was conducted for an unknown lot number neck/shoulder/wrist (nsw) 8hr product.There is no device history record (dhr) reviewed for an unknown batch number.A lot trend was not performed.The lot number is unknown.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 adverse event safety request for investigation.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.Follow-up (20jan2016): follow-up attempts are completed.No further information is expected.Follow-up (06aug2020): new information received from a product quality complaints group includes investigation results.Follow-up attempts are completed.No further information is expected.

• Brand Name: THERMACARE NECK, SHOULDER & WRIST
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 5313232
• MDR Text Key: 33943694
• Report Number: 1066015-2015-00157
• 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
• Report Date: 11/25/2015

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
• Initial Date Manufacturer Received: 11/25/2015
• Initial Date FDA Received: 12/21/2015
• Supplement Dates Manufacturer Received: 11/25/2015
• Supplement Dates FDA Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention