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

Lot Number CM3251

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

Patient Problems Burning Sensation (2146); Burn, Thermal (2530)

Event Type  Injury  

Event Description

The patch blisters her skin.She says it happened overnight when she was sleeping, and it left a long line marks on her/burning sensation [burns second degree] , using the product for ivs not for menstrual pain/the product helps with the cramps from the ivs.Helps with any other abdominal pain, lower back, back pain [intentional device use issue] ,.Case narrative:this is a spontaneous report from a contactable consumer reporting for herself.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare menstrual), device lot number cm3251, expiration date aug2022, via an unspecified route of administration from an unspecified date at unknown dosage for cramps from the ivs, abdominal pain, lower back, back pain.The patient's medical history and concomitant medications were not reported.The patient said she put one of the thermacare menstrual on and when she woke up, the patch blistered her skin.She said it happened overnight when she was sleeping, and it left a long line marks on her.She used the product before and she never had this issue.She liked the product.She had a burning sensation.She would like to know if we can advise her on what to use to get the blisters go away.She stated she had been using the product for ivs not for menstrual pain.She said the product helped with the cramps from the ivs.It helped with any other abdominal pain, lower back, back pain.She suggested that we call the product thermacare abdominal pain instead.The sample was available for evaluation.The action taken in response to the events for the product was unknown.The outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available., comment: based on the information provided, the event burns second degree as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event intentional device use issue is non-serious.The events are medically assessed as associated with the use of the device.

Manufacturer Narrative

A full investigation was not performed as providing the batch record information is the manufacturing site's requirement.Therefore, a summary investigation was performed.Based on the complaint narrative, the patient sustained burn injuries with blisters after product use.Review of the manufacturing site investigation concludes the root cause category is non assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "blister".The cause of the consumer stating the wrap caused a blister 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.Lot -specific trend was not identified.Review of complaint description concludes there is a device malfunction.Severity of harm was s3.

Event Description

Event verbatim [preferred term].The patch blisters her skin.She says it happened overnight when she was sleeping, and it left a long line marks on her/burning sensation [burns second degree], using the product for ivs not for menstrual pain/the product helps with the cramps from the ivs.Helps with any other abdominal pain, lower back, back pain [intentional device use issue].Narrative: this is a spontaneous report from a contactable consumer reporting for herself.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare menstrual), device lot number cm3251, expiration date aug2022, via an unspecified route of administration from an unspecified date at unknown dosage for cramps from the ivs, abdominal pain, lower back, back pain.The patient's medical history and concomitant medications were not reported.The patient said she put one of the thermacare menstrual on and when she woke up, the patch blistered her skin.She said it happened overnight when she was sleeping, and it left a long line marks on her.She used the product before and she never had this issue.She liked the product.She had a burning sensation.She would like to know if we can advise her on what to use to get the blisters go away.She stated she had been using the product for ivs not for menstrual pain.She said the product helped with the cramps from the ivs.It helped with any other abdominal pain, lower back, back pain.She suggested that we call the product thermacare abdominal pain instead.The sample was available for evaluation.The action taken in response to the events for the product was unknown.The outcome of the events was unknown.Summary of investigation and conclusion: a full investigation was not performed as providing the batch record information is the manufacturing site's requirement.Therefore, a summary investigation was performed.Based on the complaint narrative, the patient sustained burn injuries with blisters after product use.Review of the manufacturing site investigation concludes the root cause category is non assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "blister".The cause of the consumer stating the wrap caused a blister 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.Lot -specific trend was not identified.Review of complaint description concludes there is a device malfunction.Severity of harm was s3.Additional information has been requested and will be provided as it becomes available.Follow-up (20apr2020): new information a product quality complaint group includes summary of investigation and conclusion., comment: based on the information provided, the event burns second degree as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event intentional device use issue is non-serious.The events are medically assessed as associated with the use of the device.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.The root cause category is non-assignable (complaint not confirmed).Product effect may vary with each individual.No further investigations or actions are suggested at this time.

Manufacturer Narrative

Review of complaint description concludes there is a device malfunction.Severity of harm was s3.Summary of investigation: date of manufacture: 18sep2019 to 25sep2019.Batch cm3251 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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the second complaint for the sub class adverse event /serious/unknown received at the albany site requiring an evaluation for this batch.The previous investigations did not confirmed to have a manufacturing root cause related to the subclass.Per sop #, complaint trending guideline, effective 24feb2020, the complaint was evaluated to identify a potential trend for the subclass and lot.Per sop#, a visual evaluation was performed to identify a potential trend.Refer to trend chart lot cm3251 ae serious unknown.On the basis of this evaluation, a trend does not exist for this lot.Exped trend actions taken: there was deviation from sop-#, complaint trending guidelines, effective 24feb2020 in which the expedite trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in pr-#, action item pr-#.Site sample status was not received.

Event Description

Event verbatim [preferred term] the patch blisters her skin.She says it happened overnight when she was sleeping, and it left a long line marks on her/burning sensation [burns second degree], using the product for ivs not for menstrual pain/the product helps with the cramps from the ivs.Helps with any other abdominal pain, lower back, back pain [intentional device use issue].Narrative: this is a spontaneous report from a contactable consumer reporting for herself.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare menstrual), device lot number cm3251, expiration date aug2022, via an unspecified route of administration from an unspecified date at unknown dosage for cramps from the ivs, abdominal pain, lower back, back pain.The patient's medical history and concomitant medications were not reported.The patient said she put one of the thermacare menstrual on and when she woke up, the patch blistered her skin.She said it happened overnight when she was sleeping, and it left a long line marks on her.She used the product before and she never had this issue.She liked the product.She had a burning sensation.She would like to know if we can advise her on what to use to get the blisters go away.She stated she had been using the product for ivs not for menstrual pain.She said the product helped with the cramps from the ivs.It helped with any other abdominal pain, lower back, back pain.She suggested that we call the product thermacare abdominal pain instead.The sample was available for evaluation.The action taken in response to the events for the product was unknown.The outcome of the events was unknown.According to the product quality complaint group: review of complaint description concludes there is a device malfunction.Severity of harm was s3.Summary of investigation: date of manufacture: 18sep2019 to 25sep2019.Batch cm3251 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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the second complaint for the sub class adverse event /serious/unknown received at the albany site requiring an evaluation for this batch.The previous investigations did not confirmed to have a manufacturing root cause related to the subclass.Per sop #, complaint trending guideline, effective 24feb2020, the complaint was evaluated to identify a potential trend for the subclass and lot.Per sop#, a visual evaluation was performed to identify a potential trend.Refer to trend chart lot cm3251 ae serious unknown.On the basis of this evaluation, a trend does not exist for this lot.Exped trend actions taken: there was deviation from sop-#, complaint trending guidelines, effective 24feb2020 in which the expedite trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in pr-#, action item pr-#.Site sample status was not received.Follow-up (20apr2020): new information a product quality complaint group includes summary of investigation and conclusion.Follow-up (15may2020): follow-up attempts are completed.No further information is expected.Follow-up (13oct2020): new information received from the product quality complaint group included additional investigational result and updated trending information.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the event burns second degree as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event intentional device use issue is non-serious.The events are medically assessed as associated with the use of the device.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.The root cause category is non-assignable (complaint not confirmed).Product effect mayvary with each individual.No further investigations or actions are suggested at this time.

• 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: 9922379
• MDR Text Key: 189150982
• Report Number: 1066015-2020-00093
• 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
• Report Date: 03/20/2020

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: 08/01/2022
• Device Lot Number: CM3251
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/03/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/27/2020; 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention