MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAPS MULTI-PURPOSE JOINT PAIN; DISPOSABLE PACK, HOT

Lot Number	J52765
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: the root cause category is non-assignable (complaint not confirmed).The sample has not been received at the site for evaluation; the complaint cannot be confirmed.There were occurrences noted in transition notes involving the die cut and web tracking causing cut cells, without the defective wraps for evaluation it cannot be confirmed if this current defect is related to these occurrences.Our 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.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.
Event or Problem Description
Event verbatim [preferred term] the black powder came up off its like it initiated a heat but it was in the form of black powder [device leakage] ,.Case narrative: this is a spontaneous report from a contactable consumer reporting for mother.A (b)(6) female patient started to receive thermacare heatwrap (thermacare heatwraps multi-purpose joint pain), lot number: j52765, expiry date: apr2017, ndc number: 0573301724, upc number: (b)(4), from unknown date for neck.Medical history was none.Concomitant medications were not reported.The patient had used thermacare heat wraps for as long as they been out (in the market).She was probably been using it for about four to five years.She just opened a brand new box and opened one package out of that box and when she took the packaging off of it to use it a black powder came out of it.And she opened one of them and when she took the packaging off the black powder came up off its like it initiated a heat but it was in the form of black powder.The action taken in response to the event of the product was unknown.The outcome of the event was unknown.According to the product quality complaint group: investigation summary: the root cause category is non-assignable (complaint not confirmed).The sample has not been received at the site for evaluation; the complaint cannot be confirmed.There were occurrences noted in transition notes involving the die cut and web tracking causing cut cells, without the defective wraps for evaluation it cannot be confirmed if this current defect is related to these occurrences.Our 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.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.Follow-up (10apr2017): new information reported from a contactable consumer includes: product data (updated lot number).Follow-up (20apr2017): follow-up attempts completed.No further information expected.Follow-up (18may2017): new information received from product quality complaint group includes investigation results.Follow-up attempts are completed.No further information is expected.Follow-up (04apr2017): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment the event "use it a black powder came out of it" (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device., comment: the event "use it a black powder came out of it" (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device.

• Brand Name: THERMACARE HEATWRAPS MULTI-PURPOSE JOINT PAIN
• Common Device Name: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 9259827
• Report Number: 1066015-2019-00376
• Device Sequence Number: 16803842
• Product Code: IMD
• UDI-Device Identifier: 00305733017241
• UDI-Public: 305733017241
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/01/2017
• Device Lot Number: J52765
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 59