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

Lot Number W87447

Device Problem Use of Device Problem (1670)

Patient Problems Erythema (1840); Irritation (1941); Itching Sensation (1943); Pain (1994); Burn, Thermal (2530)

Event Date 09/07/2018

Event Type  Injury  

Event Description

I got burned really bad/my pain and suffering/burning, redness, pain [thermal burn], applied the product directly to her skin.[device use error].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), device lot number w87447, via an unspecified route of administration from an unspecified date at unknown dosage for menstrual pain.The patient medical history was not reported.The patient's concomitant medications were not reported.The patient stated "i bought thermacare heat wraps advanced menstrual pain therapy.I got burned really bad on (b)(6) 2018.It is not fair.Why this is happening to me and i am supposed to have surgery on my lower abdomen now i can't because i am burned.You guys need to do something about your products, it is not fair to me and other people.I would like the company to compensate me for my pain and suffering".The action taken in response to the event was unknown.The outcome of the event was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (09oct2018): new information received from the consumer via legal division includes: the (b)(6)-year-old patient bought thermacare menstrual (expiration date: mar2021) on (b)(6) 2018 for menstrual cramps.She used thermacare for 3 days.She left the device on for 4 hours at one time during the course of 24 hours.She applied the device to her right side lower abdomen.During usage, she detected irritation, redness and burning on (b)(6) 2018.She took it off immediately.After using thermacare, burning, redness, irritation, pain, itching and bloating developed.The patient report that the product was not heated in a microwave prior to usage and was not re-heated at all during usage.The patient did not leave the product on while she was asleep.She applied the product directly to her skin.The skin was not damaged or broken prior to usage of thermacare.The area was not bruised or swelled 48 hours prior to usage of thermacare.She checked her skin frequently while using thermacare.The thermacare was not used along with pain rubs, medicated lotions, creams or ointments.She is not under the care of a medical doctor right now, but she will go soon.She has not been to her dermatologist yet.No treatment was prescribed.She did not consult her primary physician prior to usage of thermacare.She did not have diabetes, poor circulation or heart disease, rheumatoid arthritis and pregnancy.The action taken in response to the event was permanently withdrawn on (b)(6) 2018.The outcome of the events was unknown.Follow-up (09oct2018): new information received from the consumer includes: female patient had a hysteroscopy dc on (b)(6) 2018.She was not hospitalized as a result of the events.The patient received treatment (unspecified) for pain.No treatment received for the other events.The event of pain is recovered.The patient is not recovered from suffering.The outcome of burn is unknown.Follow-up (01apr 2019): follow-up attempts are completed.No further information is expected.Follow-up (09oct2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.

Manufacturer Narrative

Summary of investigation: batch w87447, is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: 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 wraps "i got burned really bad ".The cause of the burn 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 asprovided with the wrap to avoid the risks of burns or other skin irritations.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 trend assmt.& rationale: an evaluation of the complaint history confirms that this is the fifth complaint for the sub class adverse event safety request for investigation received at the albany site requiring an evaluation for this batch.The previous complaints have not been confirmed to have a manufacturing root cause related to the subclass.Per (b)(4), complaint trending guideline, effective (b)(6) 2019, a visual evaluation was performed to identify a potential trend.On the basis of this evaluation, a trend does not exist for this batch.The sample had not been received by the site.

Event Description

Event verbatim [preferred term].I got burned really bad/my pain and suffering/burning, redness, pain [thermal burn], applied the product directly to her skin.[device use error].Narrative: this is a spontaneous report from a contactable consumer.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare menstrual), device lot number w87447, via an unspecified route of administration from an unspecified date at unknown dosage for menstrual pain.The patient medical history was not reported.The patient's concomitant medications were not reported.The patient stated "i bought thermacare heat wraps advanced menstrual pain therapy.I got burned really bad on (b)(6) 18.It is not fair.Why this is happening to me and i am supposed to have surgery on my lower abdomen now i can't because i am burned.You guys need to do something about your products, it is not fair to me and other people.I would like the company to compensate me for my pain and suffering".The action taken in response to the event was unknown.The outcome of the event was unknown.Follow-up (09oct2018): new information received from the consumer via legal division includes: the 35-year-old patient bought thermacare menstrual (expiration date: mar2021) on (b)(6) 2018 for menstrual cramps.She used thermacare for 3 days.She left the device on for 4 hours at one time during the course of 24 hours.She applied the device to her right side lower abdomen.During usage, she detected irritation, redness and burning on (b)(6) 2018.She took it off immediately.After using thermacare, burning, redness, irritation, pain, itching and bloating developed.The patient report that the product was not heated in a microwave prior to usage and was not re-heated at all during usage.The patient did not leave the product on while she was asleep.She applied the product directly to her skin on (b)(6) 2018.The skin was not damaged or broken prior to usage of thermacare.The area was not bruised or swelled 48 hours prior to usage of thermacare.She checked her skin frequently while using thermacare.The thermacare was not used along with pain rubs, medicated lotions, creams or ointments.She is not under the care of a medical doctor right now, but she will go soon.She has not been to her dermatologist yet.No treatment was prescribed.She did not consult her primary physician prior to usage of thermacare.She did not have diabetes, poor circulation or heart disease, rheumatoid arthritis and pregnancy.The action taken in response to the event was permanently withdrawn on (b)(6) 2018.The outcome of the events was unknown.Follow-up (09oct2018): new information received from the consumer includes: female patient had a hysteroscopy dc on (b)(6) 2018.She was not hospitalized as a result of the events.The patient received treatment (unspecified) for pain.No treatment received for the other events.The event of pain is recovered.The patient is not recovered from suffering.The outcome of burn is unknown.Follow-up (01apr 2019): follow-up attempts are completed.No further information is expected.Follow-up (09oct2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (15apr2020): new information received from product quality complaint group included: summary of investigation: batch w87447 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: 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 wraps "i got burned really bad ".The cause of the burn 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 asprovided with the wrap to avoid the risks of burns or other skin irritations.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 trend assmt.& rationale: an evaluation of the complaint history confirms that this is the fifth complaint for the sub class adverse event safety request for investigation received at the albany site requiring an evaluation for this batch.The previous complaints have not been confirmed to have a manufacturing root cause related to the subclass.Per (b)(4), complaint trending guideline, effective (b)(6) 2019, a visual evaluation was performed to identify a potential trend.On the basis of this evaluation, a trend does not exist for this batch.The sample had not been received by the site.

• 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: 9260662
• MDR Text Key: 174460640
• Report Number: 1066015-2019-00285
• 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
• Report Date: 09/12/2018

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2021
• Device Lot Number: W87447
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR