MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE MENSTRUAL; DISPOSABLE PACK, HOT

Health Effect - Clinical Code	Chemical Exposure (2570)
Type of Reportable Event	Malfunction
Event or Problem Description
Event verbatim [preferred term] it was against the skin in more than one place [accidental exposure to product] , there was charcoal, or whatever the black substance is, coming out of the wrap in two different spots.It was against my skin in more than one place [device leakage] ,.Case narrative:this is a spontaneous report from a contactable consumer.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare menstrual), expiration date aug2020, via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication.The patient medical history and concomitant medications were not reported.The consumer put on the product on (b)(6) 2018 ant the next time to the bathroom, there was charcoal, or whatever the black substance was, coming out of the wrap in two different spots.It was against the skin in more than one place."i didn't have it on that long", but lost the use of the wrap because of the faulty seal.The consumer further reported that regarding wrap breaking open.The reporter had a second one did it the next cycle.The upc code for the box they came out of was (b)(4).The expiration was aug2020.The action taken for the product and event outcome was unknown.Follow-up (17jan2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment the event "there was charcoal, or whatever the black substance was, coming out of the wrap in two different spots/ it was against the skin in more than one place" "device leakage" and "accidental exposure to product" were 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 events were assessed as associated with the use of the device., comment: the event "there was charcoal, or whatever the black substance was, coming out of the wrap in two different spots/ it was against the skin in more than one place" "device leakage" and "accidental exposure to product" were 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 events were assessed as associated with the use of the device.
Event or Problem Description
Event verbatim [preferred term] it was against the skin in more than one place [accidental exposure to product] , there was charcoal, or whatever the black substance is, coming out of the wrap in two different spots.It was against my skin in more than one place [device leakage].Case narrative:this is a spontaneous report from a contactable consumer.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare menstrual), expiration date aug2020, via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication.The patient medical history and concomitant medications were not reported.The consumer put on the product on (b)(6) 2018 and the next time to the bathroom, there was charcoal, or whatever the black substance was, coming out of the wrap in two different spots.It was against the skin in more than one place."i didn't have it on that long", but lost the use of the wrap because of the faulty seal.The consumer further reported that regarding wrap breaking open.The reporter had a second one did it the next cycle.The upc code for the box they came out of was 3 0573 3020 44 9.The expiration was (b)(6) 2020.The action taken for the product and event outcome was unknown.According to product quality complaint group: there is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per rpt- (b)(4) hazard analysis thermacare heat wrap product: 8 and 12 hour.Follow-up (17jan2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (07nov2019): new information received from a product quality complaint group included: impact analysis and severity of harm.Company clinical evaluation comment: the event "there was charcoal, or whatever the black substance was, coming out of the wrap in two different spots/ it was against the skin in more than one place" (device leakage) and "accidental exposure to product" were 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 events were assessed as associated with the use of the device., comment: the event "there was charcoal, or whatever the black substance was, coming out of the wrap in two different spots/ it was against the skin in more than one place" (device leakage) and "accidental exposure to product" were 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 events were assessed as associated with the use of the device.
Additional Manufacturer Narrative
Summary of investigation: this investigation was conducted for an unknown lot number menstrual 8hr product.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 heat cells damaged/leaking.Conclusion: 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 cells damaged/leaking.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.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.
Event or Problem Description
Event verbatim [preferred term] it was against the skin in more than one place [accidental exposure to product] , there was charcoal, or whatever the black substance is, coming out of the wrap in two different spots.It was against my skin in more than one place [device leakage].Case narrative:this is a spontaneous report from a contactable consumer.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare menstrual), expiration date aug2020, via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication.The patient medical history and concomitant medications were not reported.The consumer put on the product on (b)(6) 2018 and the next time to the bathroom, there was charcoal, or whatever the black substance was, coming out of the wrap in two different spots.It was against the skin in more than one place."i didn't have it on that long", but lost the use of the wrap because of the faulty seal.The consumer further reported that regarding wrap breaking open.The reporter had a second one did it the next cycle.The upc code for the box they came out of was 3 0573 3020 44 9.The expiration was aug2020.The action taken for the product and event outcome was unknown.According to product quality complaint group: there is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per rpt- (b)(4) hazard analysis thermacare heat wrap product: 8 and 12 hour.Summary of investigation: this investigation was conducted for an unknown lot number menstrual 8hr product.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 heat cells damaged/leaking.Conclusion: 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 cells damaged/leaking.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.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.Follow-up (17jan2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (07nov2019): new information received from a product quality complaint group included: impact analysis and severity of harm.Follow-up (08nov2019): new information received from a product quality complaint group included: investigation results.Company clinical evaluation comment: the event "there was charcoal, or whatever the black substance was, coming out of the wrap in two different spots/ it was against the skin in more than one place" (device leakage) and "accidental exposure to product" were 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 events were assessed as associated with the use of the device.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.Product effect varies with each individual., comment: the event "there was charcoal, or whatever the black substance was, coming out of the wrap in two different spots/ it was against the skin in more than one place" (device leakage) and "accidental exposure to product" were 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 events were assessed as associated with the use of the device.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.Product effect varies with each individual.

• Brand Name: THERMACARE MENSTRUAL
• Common Device Name: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 9258460
• Report Number: 1066015-2019-00327
• Device Sequence Number: 459860
• Product Code: IMD
• UDI-Device Identifier: 00305733020449
• UDI-Public: 305733020449
• 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,Followup
• Report Date (Section B): 01/17/2018

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/01/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 11/13/2019; 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1