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

Lot Number L44151

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Pain (1994); Burn, Thermal (2530); Fluid Discharge (2686)

Event Date 05/01/2018

Event Type  Injury  

Event Description

Event verbatim (preferred term) pain became more and more intense/ oval-shaped burns/ skin very red and very thin (thermal burn), some wet spots or a reals (wound secretion), scab, the skin was not controlled while use (device use error).Case narrative:this is a spontaneous report from a contactable other health professional reporting for herself.A (b)(6) female patient started to receive thermacare heatwrap (thermacare menstrual) expiry date mar 2018.Lot number: l44151, from (b)(6) 2018 for severe menstrual pain with severe cramps.The patient medical history was not reported.Concomitant medications were none.The patient said she was advised that she can use the product after the expiration date.Because of severe period pains and cramps, she used it in the morning to reduce the pain.The patch she has used so as always, as it had always helped very well.She used it from (b)(6) 2018 8 am to (b)(6) 2018 11:20 am.After 3 hours she noticed that the pain became more and more intense.When going to the toilet, oval-shaped burns, just in the area of the dark heat points.Skin very red and very thin, some wet spots or areals! she has immediately taken off the patch.She had to treat the burns for a week with various ointments, compresses and sprays.Later scab formations in (b)(6) 2018.After more than a week it was healed again.The reporter also provided the following information: bright non-sensitive skin, no skin disease, the color of the thermacare package was red, the package was completely consumed, no other products regarding indication were used before, no gym while use of the drug, the skin was not controlled while use.The reporter stated the event burns was assessed as non-serious.The action taken in response to the event of the product was withdrawn due to the event on (b)(6) 2018.The outcome of the event "the skin was not controlled while use" was unknown and for other events was resolved on (b)(6) 2018.Additional information has been requested and will be provided as it becomes available.Follow-up ((b)(6) 2018): new information received from the same contactable pharmacist referring to self: event outcome.Follow-up ((b)(6) 2018): new information received from the same contactable other hcp includes: patient age, product data (therapy date, indication and action taken) and new events ("some wet spots or areals", "scab" and "the skin was not controlled while use").The event "burns" was upgraded to serious and reportable.Company clinical evaluation comment: based on the information provided, the events of thermal burn, wound secretion, scab and device use error as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events of thermal burn, wound secretion, scab and device use error as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.

Manufacturer Narrative

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 an adverse event.The cause of the an adverse event 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.

Event Description

Event verbatim [preferred term] pain became more and more intense/ oval-shaped burns/ skin very red and very thin [thermal burn] , some wet spots or areals [wound secretion] , scab [scab] , the skin was not controlled while use [device use error] ,.Case narrative:this is a spontaneous report from a contactable other health professional reporting for herself.A (b)(6)-year-old female patient started to receive thermacare heatwrap (thermacare menstrual) expiry date mar2018.Lot number: l44151, from (b)(6) 2018 for severe menstrual pain with severe cramps.The patient medical history was not reported.Concomitant medications were none.The patient said she was advised that she can use the product after the expiration date.Because of severe period pains and cramps, she used it in the morning to reduce the pain.The patch she has used so as always, as it had always helped very well.She used it from (b)(6) 2018 8 am to (b)(6) 2018 11:20 am.After 3 hours she noticed that the pain became more and more intense.When going to the toilet, oval-shaped burns, just in the area of the dark heat points.Skin very red and very thin, some wet spots or areals! she has immediately taken off the patch.She had to treat the burns for a week with various ointments, compresses and sprays.Later scab formations in (b)(6) 2018.After more than a week it was healed again.The reporter also provided the following information: bright non-sensitive skin, no skin disease, the color of the thermacare package was red, the package was completely consumed, no other products regarding indication were used before, no gym while use of the drug, the skin was not controlled while use.The reporter stated the event burns was assessed as non-serious.The action taken in response to the event of the product was withdrawn due to the event on (b)(6) 2018.The outcome of the event "the skin was not controlled while use" was unknown and for other events was resolved on (b)(6) 2018.According to the product quality complaint group: 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 an adverse event.The cause of the an adverse event 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.Additional information has been requested and will be provided as it becomes available.Follow-up ((b)(6) 2018): new information received from the same contactable pharmacist referring to self: event outcome.Follow-up ((b)(6) 2018): new information received from the same contactable other hcp includes: patient age, product data (therapy date, indication and action taken) and new events ("some wet spots or areals", "scab" and "the skin was not controlled while use").The event "burns" was upgraded to serious and reportable.Follow-up ((b)(6) 2018): new information received from the product quality complaint group included investigational results.Follow-up attempts completed.No further information expected.Company clinical evaluation comment: based on the information provided, the events of thermal burn, wound secretion, scab and device use error as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.In the case narrative there is evidence of device use error which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the events of thermal burn, wound secretion, scab and device use error as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.In the case narrative there is evidence of device use error which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is 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
• Manufacturer Contact: b green ; 235 e42nd street; new york, NY 10017
• MDR Report Key: 7587943
• MDR Text Key: 110659381
• Report Number: 1066015-2018-00078
• 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: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/22/2018

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: 03/01/2018
• Device Lot Number: L44151
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/11/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR