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

Lot Number EC2277

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

Patient Problems Pain (1994); Skin Tears (2516)

Event Date 12/10/2020

Event Type  Injury  

Event Description

Event verbatim: pain ripped my skin off ,skin exfoliation.Narrative: this is a spontaneous report from a contactable consumer (patient).A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare menstrual), via an unspecified route of administration from an unspecified date at an unknown frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient was using the menstrual cramp pad, correctly.Sticky side in the underwear, soft side against skin.And two hours into wearing it the patient started being in pain so patient went to the restroom to see why and when the patient pulled pants and underwear down, the soft side ripped the skin off on an unspecified date.The patient was very concerned about why the product did this.The patient can send pictures then if needed.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.

Event Description

Event verbatim [preferred term] pain [pain], ripped my skin off [skin exfoliation], , narrative: this is a spontaneous report from a contactable consumer (patient).A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare menstrual) lot #ec2277, expiration date 30jun2023, via an unspecified route of administration from an unspecified date at an unknown frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient was using the menstrual cramp pad, correctly.Sticky side in the underwear, soft side against skin.And two hours into wearing it the patient started being in pain so patient went to the restroom to see why and when the patient pulled pants and underwear down, the soft side ripped the skin off on an unspecified date.The patient was very concerned about why the product did this.The patient can send pictures then if needed.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.Follow-up (16dec2020): new information received from a product quality complaint group included product lot number and expiration date.

Event Description

Event verbatim [preferred term].Pain [pain], ripped my skin off [skin exfoliation], narrative: this is a spontaneous report from a contactable consumer (patient).A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare menstrual) lot #ec2277, expiration date 30jun2023, via an unspecified route of administration from an unspecified date at an unknown frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient was using the menstrual cramp pad, correctly.Sticky side in the underwear, soft side against skin.And two hours into wearing it the patient started being in pain so patient went to the restroom to see why and when the patient pulled pants and underwear down, the soft side ripped the skin off on an unspecified date.The patient was very concerned about why the product did this.The patient can send pictures then if needed.The action taken in response to the event for thermacare heatwrap was unknown.The event outcome was unknown.According to product quality group: complaint sub-class: adverse event/serious/unknown.Summary of investigation: batch ec2277 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: 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 "the soft side ripped my skin off." the cause of the consumer reporting "the soft side ripped my skin off" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The plant has reviewed the dhr for this lot from a manufacturing perspective.No quality issues were identified upon this review of dhr, 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 lot is not impacted by this complaint.Lot trend assmt.& rationale: an evaluation of the complaint confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this lot.Lot trend actions taken: a trend does not exist for this lot.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, a trend does not exist for the subclass of adverse event/serious/unknown for menstrual 8hr products the data did not show an increase over time (36 months).There is not a trend identified for the subclass of adverse event/serious/unknown for menstrual 8hr products, refer to attachment trending chart adverse event serious unknown menstrual (b)(6) 2017 to (b)(6) 2020.A return sample has not been received at the site.Follow-up (16dec2020): new information received from a product quality complaint group included product lot number and expiration date.Follow-up (22dec2020): follow-up attempts are completed.No further information is expected.Follow-up (05jan2021): new information received from product quality complaint group includes investigation results.Follow-up attempts are completed.No further information is expected.

Manufacturer Narrative

Complaint sub-class: adverse event/serious/unknown.Summary of investigation: batch ec2277 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: 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 "the soft side ripped my skin off." the cause of the consumer reporting "the soft side ripped my skin off" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The plant has reviewed the dhr for this lot from a manufacturing perspective.No quality issues were identified upon this review of dhr, 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 lot is not impacted by this complaint.Lot trend assmt.& rationale: an evaluation of the complaint confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this lot.Lot trend actions taken: a trend does not exist for this lot.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, a trend does not exist for the subclass of adverse event/serious/unknown for menstrual 8hr products the data did not show an increase over time (36 months).There is not a trend identified for the subclass of adverse event/serious/unknown for menstrual 8hr products, refer to attachment trending chart adverse event serious unknown menstrual (b)(6) 2017 to (b)(6) 2020.A return sample has not been received at the site.

Manufacturer Narrative

Complaint sub-class: adverse event/serious/unknown.Summary of investigation:batch ec2277 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: 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 "the soft side ripped my skin off." the cause of the consumer reporting "the soft side ripped my skin off" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The plant has reviewed the dhr for this lot from a manufacturing perspective.No quality issues were identified upon this review of dhr, 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 lot is not impacted by this complaint.Lot trend assmt.& rationale:an evaluation of the complaint confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this lot.Lot trend actions taken: a trend does not exist for this lot.Exped trend assmt.& rationale:an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, a trend does not exist for the subclass of adverse event/serious/unknown for menstrual 8hr products the data did not show an increase over time (36 months).There is not a trend identified for the subclass of adverse event/serious/unknown for menstrual 8hr products, refer to trending chart adverse event serious unknown menstrual 10dec2017 to 10dec2020.A return sample has not been received at the site.

Event Description

Event verbatim [preferred term] pain [pain], ripped my skin off [skin exfoliation].Narrative: this is a spontaneous report from a contactable consumer (patient).A 26-year-old female patient started to receive thermacare heatwrap (thermacare menstrual) lot #ec2277, expiration date 30jun2023, via an unspecified route of administration on 10dec2020 used at one time for cramps.The patient medical history was not reported.There were no concomitant medications.The patient was using the menstrual cramp pad, correctly.Sticky side in the underwear, soft side against skin.And two hours into wearing it the patient started being in pain so patient went to the restroom to see why and when the patient pulled pants and underwear down, the soft side ripped the skin off on (b)(6) 2020.The patient was very concerned about why the product did this.The patient can send pictures then if needed.The action taken in response to the event for thermacare heatwrap was permanently withdrawn on (b)(6) 2020.The event outcome was resolved on unknown date.According to product quality group: complaint sub-class: adverse event/serious/unknown.Summary of investigation:batch ec2277 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: 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 "the soft side ripped my skin off." the cause of the consumer reporting "the soft side ripped my skin off" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The plant has reviewed the dhr for this lot from a manufacturing perspective.No quality issues were identified upon this review of dhr, 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 lot is not impacted by this complaint.Lot trend assmt.& rationale:an evaluation of the complaint confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this lot.Lot trend actions taken: a trend does not exist for this lot.Exped trend assmt.& rationale:an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, a trend does not exist for the subclass of adverse event/serious/unknown for menstrual 8hr products the data did not show an increase over time (36 months).There is not a trend identified for the subclass of adverse event/serious/unknown for menstrual 8hr products, refer to trending chart adverse event serious unknown menstrual (b)(6) 2017 to (b)(6) 2020.A return sample has not been received at the site.Follow-up (16dec2020): new information received from a product quality complaint group included product lot number and expiration date.Follow-up (22dec2020): follow-up attempts are completed.No further information is expected.Follow-up (05jan2021): new information received from product quality complaint group includes investigation results.Follow-up attempts are completed.No further information is expected.Follow-up (26jan2021): new information received from the same contactable consumer included: patient age, gender, concomitant product(none), product therapy date and event data (onset date, no treatment received and outcome).Follow-up attempts are completed.No further information is expected.

• Brand Name: THERMACARE MENSTRUAL
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 11047944
• MDR Text Key: 223726418
• Report Number: 1066015-2020-00204
• 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,Followup,Followup
• Report Date: 12/10/2020

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2023
• Device Lot Number: EC2277
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/21/2020; 01/08/2021; 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR
• Patient Weight: 82