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

Lot Number L44886

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Nausea (1970); Nerve Damage (1979); Hot Flashes/Flushes (2153)

Event Date 06/01/2015

Event Type  Other  

Event Description

A severe allergic reaction [hypersensitivity], full body redness [generalised erythema], heat [feeling hot], itchiness/itchy [pruritus], nauseous [nausea], issues with circulation/nerve damage [nerve injury].Case description: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age and ethnicity started to receive thermacare heatwrap (thermacare menstrual) via an unspecified route of administration from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient purchased the product on (b)(6) 2015 and she placed one on in the evening for 2-3 hours and another one later that night for 2-3 hours.She used as directed and she woke up to a full body redness, heat and itchiness.She was then nauseous and continued to stay red, hot and itchy through saturday and sunday.On (b)(6) 2015,.She decided to call into work and went early to an urgent care clinic.The doctor there told her she more than likely had a severe allergic reaction to this product (because the redness started on her belly and hands and spread through saturday and sunday to my entire body).She received a steroid shot right away and two prescriptions, including another steroid.She ended up having to go back to (b)(6) 2015, because she was having issues with circulation, the doctor explained this was an after effect of the severe allergic reaction she received and that there was nerve damage, but would get better with time and to be "patient".Action taken with the product was unknown.Clinical outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available.

Manufacturer Narrative

Company clinical evaluation comment/case comment: based on the information provided, the events severe allergic reaction, generalized erythema, pruritus, feeling hot, nausea, and nerve injury are assessed as associated with the device use.This case meets (b)(6) and 30-day fda reportability.

Manufacturer Narrative

Follow-up (june 30, 2015): new information received from a contactable consumer includes: patient details, lot number, suspect product indication, suspect product start/stop date, action taken with suspect product, additional event of hands peeling, event onset date, event recovery date and event outcome.Company clinical evaluation comment: based on the information provided, the events severe allergic reaction, generalized erythema, pruritus, skin exfoliation, feeling hot, nausea, and nerve injury are assessed as associated with the device use.This case meets follow up 10-day eu and 30-day fda reportability.

Event Description

Hands are peeling terribly (skin exfoliation).

Manufacturer Narrative

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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The product effect may vary with each individual.

Event Description

Case description: this is a spontaneous report from a contactable consumer.A (b)(6) female patient of an unspecified ethnicity started to receive thermacare heatwrap (thermacare menstrual) (lot #: l44886, expiration date: feb2018) from an unspecified date in (b)(6) 2015 for menstrual cramps.The patient's medical history and concomitant medications were not reported.The patient purchased the product on (b)(6) 2015 and placed a heatwrap on in the evening for 2-3 hours and another one on later that night for 2 to 3 hours.She used as directed and she woke up to a full body redness, heat and itchiness.She was then nauseous and continued to stay red, hot and itchy through saturday and sunday.On (b)(6) 2015, she decided to call into work and went early to an urgent care clinic.The doctor there told her she more than likely had a severe allergic reaction to this product (because the redness started on her belly and hands and spread through saturday and sunday to entire body).She received an unspecified steroid shot right away and 2 prescriptions, including another steroid.She ended up having to go back to the urgent care clinic on (b)(6) 2015, because she was having issues with circulation.The doctor explained this was an after effect of the severe allergic reaction she received and that there was nerve damage, but would get better with time and to be "patient".The patient reported on an unspecified date in (b)(6) 2015, her hands were peeling.Action taken with the product was permanently withdrawn on an unspecified date in (b)(6) 2015.Therapeutic measures received included an unspecified steroid shot and 2 prescriptions, including another steroid.Clinical outcome of the event hands peeling was not resolved.Clinical outcome of nerve damage was resolving.Clinical outcome of the other events was resolved on an unspecified date in (b)(6) 2015.According to the product quality complaint group: 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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The product effect may vary with each individual.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the events severe allergic reaction, generalized erythema, pruritus, feeling hot, nausea, and nerve injury are assessed as associated with the device use.This case meets initial 10-day eu and 30-day fda reportability.Follow-up (30jun2015): new information received from a contactable consumer includes: patient details, lot number, suspect product indication, suspect product start/stop date, action taken with suspect product, additional event of hands peeling, event onset date, event recovery date and event outcome.Follow-up attempts completed.No further information expected.Follow-up (19aug2015): 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 severe allergic reaction, generalized erythema, pruritus, skin exfoliation, feeling hot, nausea, and nerve injury are assessed as associated with the device use.This case meets final 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events severe allergic reaction, generalized erythema, pruritus, skin exfoliation, feeling hot, nausea, and nerve injury are assessed as associated with the device use.This case meets final 10-day eu and 30-day fda reportability.Evaluation summary: 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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The product effect may vary with each individual.

• Brand Name: THERMACARE MENSTRUAL
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): OFIZER CONSUMER HEALTH CARE; albany GA
• Manufacturer (Section G): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte dr.; albany GA 31705
• Manufacturer Contact: 219 east 42nd st.; new york, NY 10017 ; 2127335544
• MDR Report Key: 4865669
• MDR Text Key: 6042466
• Report Number: 1066015-2015-00073
• 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,consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 06/10/2015

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: 02/01/2018
• Device Lot Number: L44886
• Initial Date Manufacturer Received: 06/10/2015
• Initial Date FDA Received: 06/22/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/08/2015; 09/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR