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

Device Problems Use of Device Problem (1670); Patient-Device Incompatibility (2682)

Patient Problem Numbness (2415)

Event Date 03/12/2017

Event Type  Injury  

Event Description

Numbness in that area/ on her leg/was on long enough to numbness lasted 4 weeks [hypoaesthesia], used some thermacare shoulder wraps on her leg/ put it on her thigh [device use issue] case narrative:this is a spontaneous report from a contactable consumer.A (b)(6)-year-old female patient started to use thermacare heatwrap (thermacare joint & arthritis pain neck, shoulder & wrist) from (b)(6) 2017 for pain in leg.The patient's medical history was reported as none.There were no concomitant medications.The patient bought the product over the counter.On sunday, (b)(6) 2017 the patient reported she used some shoulder heatwraps on her leg.It did not stay on very long as she was working and it fell off but she experienced numbness in that area that lasted 4 weeks.The patient stated she has put it on her thigh because she had lot of pain in her leg.Pain was on her thigh, on her hip to the knee.The patient was hospitalized on an unspecified date as a result of numbness in that area/on her leg.Medical intervention was reported as none.Action taken with the suspect product was permanently withdrawn on an unspecified date.Clinical outcome of the event "numbness in that area/ on her leg" was resolved on an unspecified date in (b)(6) 2017 and for "used some thermacare shoulder wraps on her leg/ put it on her thigh" was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (25apr2017): new information received from a contactable consumer includes: action taken with suspect product, event outcome and patient hospitalization as a result of numbness in that area/on her leg.Follow-up (21jun2017): follow-up attempts are completed.No further information is expected.Follow-up (25apr2017): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment: based on the available information, the patient reported that "numbness in that area/ on her leg/was on long enough to numbness lasted 4 weeks" requiring hospital admission is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure; and assessed as associated with the use of the device.Event device use issue is non-serious.The events are medically assessed as associated with the use of the device., comment: based on the available information, the patient reported that "numbness in that area/ on her leg/was on long enough to numbness lasted 4 weeks" requiring hospital admission is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure; and assessed as associated with the use of the device.Event device use issue is non-serious.The events are medically assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term].Numbness in that area/ on her leg/was on long enough to numbness lasted 4 weeks [hypoaesthesia], used some thermacare shoulder wraps on her leg/ put it on her thigh [device use issue].Narrative: this is a spontaneous report from a contactable consumer.A 74-year-old female patient started to use thermacare heatwrap (thermacare joint & arthritis pain neck, shoulder & wrist) from (b)(6) 2017 for pain in leg.The patient's medical history was reported as none.There were no concomitant medications.The patient bought the product over the counter.On sunday, (b)(6) 2017 the patient reported she used some shoulder heatwraps on her leg.It did not stay on very long as she was working and it fell off but she experienced numbness in that area that lasted 4 weeks.The patient stated she has put it on her thigh because she had lot of pain in her leg.Pain was on her thigh, on her hip to the knee.The patient was hospitalized on an unspecified date as a result of numbness in that area/on her leg.Medical intervention was reported as none.The patient did not have the heatwrap anymore.The device was not available for evaluation.Action taken with the suspect product was permanently withdrawn on an unspecified date.Clinical outcome of the event "numbness in that area/ on her leg" was resolved on an unspecified date in (b)(6) 2017 and for "used some thermacare shoulder wraps on her leg/ put it on her thigh" was unknown.According to product quality complaints, reasonably suggest device malfunction was no.Severity of harm was not applicable.Site sample status was not received.This investigation was conducted for an unknown lot number neck/shoulder/wrist (nsw) 8-hour product.There is not a trend identified related for the subclass adverse event safety request for investigation.Conclusion was as follows 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 (25apr2017): new information received from a contactable consumer includes: action taken with suspect product, event outcome and patient hospitalization as a result of numbness in that area/on her leg.Follow-up (21jun2017): follow-up attempts are completed.No further information is expected.Follow-up (25apr2017): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (19dec2019): follow-up attempts are completed.No further information is expected.Follow-up (01may2020): new information received from product quality complaints included: investigation results and additional information (the device was not available for evaluation).Follow-up attempts are completed.No further information is expected.

Manufacturer Narrative

Site sample status was not received.This investigation was conducted for an unknown lot number neck/shoulder/wrist (nsw) 8-hour product.There is not a trend identified related for the subclass adverse event safety request for investigation.Conclusion was as follows 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.

• Brand Name: THERMACARE JOINT & ARTHRITIS PAIN 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: 9259825
• MDR Text Key: 184864703
• Report Number: 1066015-2019-00350
• 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: 03/17/2017

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 91