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

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

Patient Problems Pain (1994); Injury (2348)

Event Type  Injury  

Event Description

It made my neck hurt [neck pain] ,.Case narrative:this is a spontaneous report from a pfizer-sponsored program thermacare power reviews.A contactable consumer reported that a patient of unspecified age and gender started to receive thermacare heatwrap (thermacare lower back & hip), from an unspecified date at an unspecified frequency for back pain.The patient medical history and concomitant medications were not reported.The patient stated "it's okay for back pain but it made my neck hurt".The action taken in response to the event for thermacare heatwrap was unknown.The event outcome was unknown.Additional information has been requested and will be provided as it becomes available., comment: based on the information provided, the event of neck pain as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.

Manufacturer Narrative

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 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 product being packaged.Based on the complaint narrative, patient reported neck pain during product use.The review of complaint description concludes there is no device malfunction.Site sample status: not returned.

Event Description

It made my neck hurt [neck pain], narrative: this is a spontaneous report from a pfizer-sponsored program thermacare power reviews.A contactable consumer reported that a patient of unspecified age and gender started to receive thermacare heatwrap (thermacare lower back & hip), from an unspecified date at an unspecified frequency for back pain.The patient medical history and concomitant medications were not reported.The patient stated "it's okay for back pain but it made my neck hurt".The action taken in response to the event for thermacare heatwrap was unknown.The event outcome was unknown.Product quality complaints provided the following investigation results: 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 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 product being packaged.Based on the complaint narrative, patient reported neck pain during product use.The review of complaint description concludes there is no device malfunction.Site sample status: not returned.Follow-up (22apr2020): follow-up attempts are completed.No further information is expected.Follow-up (20may2020): new information from product quality complaints includes: investigation results.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the event of neck pain as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.

• 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: 9944107
• MDR Text Key: 189452963
• Report Number: 1066015-2020-00095
• 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: 03/27/2020

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: Not provided
• Initial Date FDA Received: 04/09/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention