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

Lot Number W36662

Device Problem Overheating of Device (1437)

Patient Problems Pain (1994); Injury (2348); Burn, Thermal (2530)

Event Date 11/14/2018

Event Type  Injury  

Event Description

Event verbatim: [preferred term] burned [thermal burn], open wound [wound].Case narrative: this is a spontaneous report from a contactable consumer via us fda (mw5081759).This consumer of unknown age and gender started to receive thermacare heatwrap (thermacare heatwrap) lot#: w36662, expiration date: 30apr2021, from unknown date for menstrual pain.Medical history and concomitant medications were not reported.Consumer was burned by thermacare heatwraps for menstrual pain on (b)(6) 2018.Consumer had an open wound the size/shape of a heat cell on the right side of abdomen.Device was available for evaluation.The action taken in response to the events of the product was unknown.The outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available.

Event Description

Event verbatim [preferred term] burned [thermal burn] , open wound [wound].Case narrative:this is a spontaneous report from a contactable consumer via us fda (mw5081759).This consumer of unknown age and gender started to receive thermacare heatwrap (thermacare heatwrap) lot#: w36662, expiration date: 30apr2021, from unknown date for menstrual pain.Medical history and concomitant medications were not reported.Consumer was burned by thermacare heatwraps for menstrual pain on (b)(6) 2018.Consumer had an open wound the size/shape of a heat cell on the right side of abdomen.Device was available for evaluation.The action taken in response to the events of the product was unknown.The outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available.Amendment: this follow-up report is being submitted to amend previously reported information: seriousness criteria "medically significant" was checked for the events "burned" and "open wound".

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 "was burned by thermacare heat wraps for menstrual pain".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.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

Burned [thermal burn], open wound [wound].Case narrative:this is a spontaneous report from a contactable consumer via us fda (mw5081759).This consumer of unknown age and gender started to receive thermacare heatwrap (thermacare heatwrap) lot#: w36662, expiration date: 30apr2021, from unknown date for menstrual pain.Medical history and concomitant medications were not reported.Consumer was burned by thermacare heatwraps for menstrual pain on (b)(6) 2018.The patient had an open wound the size/shape of a heat cell on the right side of abdomen.Device was available for evaluation.Per 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 "was burned by thermacare heat wraps for menstrual pain".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.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.The action taken in response to the events of the product was unknown.The outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available.Amendment: this follow-up report is being submitted to amend previously reported information: seriousness criteria "medically significant" was checked for the events "burned" and "open wound".Follow up (24jan2019): new information received from a product quality complaint group includes: investigation summary.

• Brand Name: THERMACARE HEATWRAP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 8195770
• MDR Text Key: 131476858
• Report Number: 1066015-2018-00204
• 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: 12/14/2018

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: 04/30/2021
• Device Lot Number: W36662
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/26/2018
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/31/2018; 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention