MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE NECK, SHOULDER & WRIST; DISPOSABLE PACK, HOT

Lot Number T65598 10/05

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Event Description

Event verbatim [preferred term] suffered a burn to the skin behind my neck/blister [burns second degree].Case narrative: this is a spontaneous report from a contactable consumer.A male patient of unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) device lot number: t65598 10/05, expiration date: sep2020, from an unspecified date at an unspecified frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient reported that "i have been a user of this product for many years.Over the weekend, i used the neck heat pad and apparently, suffered a burn to the skin behind my neck.I have pictures of the damage to the skin as well as the product, the product packaging and the box.I am retaining all of it".Upon follow up on 14dec2018, the patient stated "i will retain the product as instructed.I purchased a total of 6 boxes of the thermacare heatwrap, advanced neck pain therapy, up to 16 hours of pain relief.Each box has 3 heatwraps for a total of 18 heat wraps.I only opened 1 box and used 1 heat wrap, leaving 17 unopened.I will not be using any of those 17 in fear of a repeated burn.I'm attaching a copy of the (company name) invoice as well as a photo of the burn on day 1".The photo provided by reporter indicated blister occurred in the burn.The action taken in response to the event was permanently withdrawn, the outcome of the event was unknown.Additional information has been requested and will be provided as it becomes available.Follow up (14dec2018): new information received from a contactable consumer included: patient gender, lot number, expiration date, and action taken.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the event of burns second degree as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device., comment: based on the information provided, the event of burns second degree as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.

Event Description

Suffered a burn to the skin behind my neck/blister [burns second degree].Case narrative: this is a spontaneous report from a contactable consumer.A male patient of unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) device lot number: t65598 10/05, expiration date: sep2020, from an unspecified date at an unspecified frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient reported that "i have been a user of this product for many years.Over the weekend, i used the neck heat pad and apparently, suffered a burn to the skin behind my neck.I have pictures of the damage to the skin as well as the product, the product packaging and the box.I am retaining all of it".Upon follow up on (b)(6) 2018, the patient stated "i will retain the product as instructed.I purchased a total of 6 boxes of the thermacare heatwrap, advanced neck pain therapy, up to 16 hours of pain relief.Each box has 3 heatwraps for a total of 18 heat wraps.I only opened 1 box and used 1 heat wrap, leaving 17 unopened.I will not be using any of those 17 in fear of a repeated burn.I'm attaching a copy of the (company name) invoice as well as a photo of the burn on day 1".The photo provided by reporter indicated blister occurred in the burn.The action taken in response to the event was permanently withdrawn, the outcome of the event was unknown.Conclusion from the product quality complaint group included: 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 she "suffered a burn to the skin behind my neck".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.Follow up (14dec2018): new information received from a contactable consumer included: patient gender, lot number, expiration date, and action taken.Follow-up (11jan2019): new information received from product quality complaints included: investigational results.Company clinical evaluation comment: based on the information provided, the event of burns second degree as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is 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.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the event of burns second degree as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is 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.No remedial action/corrective action/field safety corrective action is suggested at this time.

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 she "suffered a burn to the skin behind my neck".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.

• Brand Name: THERMACARE NECK, SHOULDER & WRIST
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 8195766
• MDR Text Key: 131515995
• Report Number: 1066015-2018-00208
• 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: 12/10/2018

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: 09/01/2020
• Device Lot Number: T65598 10/05
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/26/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention