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

Lot Number	T98297
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	02/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports having "a very low blood sugar reading after wearing the product for an hour." the cause of an adverse event is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.
Event or Problem Description
Very low blood sugar after using product for an hour [blood glucose decreased].Case narrative: this is a spontaneous report from a contactable consumer reporting for himself.A (b)(6)-year-old male patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number t98297, expiration date jan2021, udi number: (b)(4), via an unspecified route of administration from (b)(6) 2019 used the product for 1-2 hours for lower back pain.Medical history included ongoing lower back pain.Concomitant medication included tramadol 0.5mg tablet from about 3 years before (2016) orally at 0.5mg twice daily for lower back pain.The patient stated he tried the heat wrap on (b)(6) 2019 and was wondering if there were any reports of a diabetic patient having a very low blood sugar reading after wearing the product for an hour.He verified that this happened to him on (b)(6) 2019.A sample of the product was not available to be returned.The action taken for the product and event outcome was unknown.According to product quality group: investigation summary: the root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports having "a very low blood sugar reading after wearing the product for an hour." the cause of an adverse event is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Follow-up (15may2019): follow-up attempts are completed.No further information is expected.Follow-up (16may2019): new information received from product quality complaint group includes investigation results.Follow-up attempts are completed.No further information is expected.Follow-up (26feb2019): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment: based on the information provided, the event blood glucose decreased 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., comment: based on the information provided, the event blood glucose decreased 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.
Additional Manufacturer Narrative
The root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports having "a very low blood sugar reading after wearing the product for an hour." the cause of an adverse event is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.
Event or Problem Description
Event verbatim [preferred term] very low blood sugar after using product for an hour [blood glucose decreased] ,.Case narrative:this is a spontaneous report from a contactable consumer reporting for himself.A 70-year-old male patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number t98297, expiration date jan2021, udi number: (b)(4), via an unspecified route of administration from 25feb2019 used the product for 1-2 hours for lower back pain.Medical history included ongoing lower back pain.Concomitant medication included tramadol 0.5mg tablet from about 3 years before (2016) orally at 0.5mg twice daily for lower back pain.The patient stated he tried the heat wrap on (b)(6) 2019 and was wondering if there were any reports of a diabetic patient having a very low blood sugar reading after wearing the product for an hour.He verified that this happened to him on (b)(6) 2019.A sample of the product was not available to be returned.The action taken for the product and event outcome was unknown.According to product quality group: investigation summary: the root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports having "a very low blood sugar reading after wearing the product for an hour." the cause of an adverse event is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Additional information received from product quality group included severity of harm was s3.Follow-up (15may2019): follow-up attempts are completed.No further information is expected.Follow-up (16may2019): new information received from product quality complaint group includes investigation results.Follow-up attempts are completed.No further information is expected.Follow-up (26feb2019): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (04nov2019): new information received from a product quality complaint group included "severity of harm" level.Company clinical evaluation comment: based on the information provided, the event blood glucose decreased 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., comment: based on the information provided, the event blood glucose decreased 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
• Common Device Name: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 9261098
• Report Number: 1066015-2019-00370
• Device Sequence Number: 14090913
• Product Code: IMD
• UDI-Device Identifier: 00305733010969
• UDI-Public: 305733010969
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K953442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2019

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/01/2021
• Device Lot Number: T98297
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 11/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRAMADOL; TRAMADOL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 50