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

Lot Number L30381

Device Problem Overheating of Device (1437)

Patient Problems Skin Tears (2516); Tissue Breakdown (2681)

Event Date 06/16/2015

Event Type  Other  

Event Description

Open wound, patch was very warm [product quality issue], skin was gone [skin exfoliation].Case description: this is a spontaneous report from a contactable pharmacist.A (b)(6) pt of an unspecified ethnicity started to use thermacare heatwrap (thermacare menstrual), (device lot #l30381), (b)(6) 2015, single for menstrual pain.The pt medical history was not reported.There were no concomitant medications.It was reported that the patch was very warm and after removal of the patch the skin was gone and she suffered from an open wound on (b)(6) 2015.The action taken in response to the events for thermacare heatwrap was permanently withdrawn on (b)(6) 2015.The outcome of the events was unk.Add'l info has been requested and will be provided as it becomes available.

Manufacturer Narrative

Company clinical eval comment: based on the info provided, the event open wound and skin was gone upon the removal of the patch as described in this case is considered a serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The event 'patch was very warm' is considered associated with the device.This case meets initial 10-day eu and 30-day fda reportability.

Manufacturer Narrative

According to the product quality complaint group: the plant has reviewed this batch from a manufacturing and technical 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.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.The product effect may vary with each individual.Follow-up ((b)(6) 2015): new information received from the product quality complaint group included investigational results.Follow-up attempts completed.No further information expected.

Manufacturer Narrative

Follow up (july 16, 2015): new information received from a contactable pharmacist includes: therapeutic measures taken, no hospitalization required, additional events of 2nd degree burn and scar, events outcome and event recovery date.Case closed.Follow-up attempts completed.No further information expected.

Event Description

Painful burn blister at 2 sites approximately 0.5 cm in size [burns second degree].Scarring [scar].Concomitant medications were reported as none.On (b)(6) 2015, the patient reported she wore the heatwrap for the very first time and it was very warm.After removal of the wrap, the patient noted the skin was gone.She mentioned she suffered from an open wound, wet and painful burn blister at 2 sites approximately 0.5 cm in size.The patient reported she experienced scarring as a result of the events on an unspecified date.Action taken in response to the events was permanently withdrawn on (b)(6) 2015.Therapeutic measures received included an unspecified ointment with a patch to cover the wound on an unspecified date.No hospitalization was required as a result of the events.Clinical outcome of the events was resolved with sequelae on (b)(6) 2015.The pharmacist's causality assessment was reported as related.

• Brand Name: THERMACARE MENSTRUAL
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; albany GA
• Manufacturer (Section G): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte dr; albany GA 31705
• Manufacturer Contact: 219 e 42nd st; new york, NY 10017 ; 2127335544
• MDR Report Key: 4872136
• MDR Text Key: 6061511
• Report Number: 1066015-2015-00076
• 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
• Type of Report: Initial
• Report Date: 06/18/2015

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 Lot Number: L30381
• Initial Date Manufacturer Received: 06/18/2015
• Initial Date FDA Received: 06/25/2015
• 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: 23 YR