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

Device Problems Leak/Splash (1354); Material Split, Cut or Torn (4008)

Patient Problem Burn, Thermal (2530)

Event Type  malfunction  

Manufacturer Narrative

The root cause category is non-assignable (complaint not confirmed as a quality defect).Our manufacturing operations employ quality control procedures which include in-process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.There is not a trend identified for the subclass of adverse event safety request for investigation for nsw 8 products.This is a potential device malfunction s3-skin burn- per rpt- # bridging pfizer hal severity numbers applied in the thermacare heatwrap rmp, effective 28sep2018, version 1.0.A site investigation was conducted on production records, a return sample was not received.A device malfunction was not identified during records review.

Event Description

Event verbatim [preferred term] the wrapping had a tear in it and it leaked onto her hand [accidental exposure to product], her the wrapping had a tear in it and it leaked onto her hand [device leakage], they were burning.She had a large burn on her left middle finger [thermal burn].Case narrative:this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), via an unspecified route of administration from an unspecified date, for an unspecified indication.Medical history and concomitant medications were not reported.The patient stated she recently was using a thermacare heat wrap on her wrist when "unbeknownst" to her the wrapping had a tear in it and it leaked onto her hand.She immediately washed her hands but they were burning.She had a large burn on her left middle finger.The action taken for the product and events outcome was unknown.Per product quality complaint group on 08jan2019: investigation summary the root cause category is non-assignable (complaint not confirmed).Our manufacturing operations employ quality control procedures which include in-process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.On 18mar2019, the product quality complaint group reported updated investigation summary: there is not a trend identified for the subclass of adverse event safety request for investigation for nsw 8 products.This is a potential device malfunction s3-skin burn- per rpt- # bridging pfizer hal severity numbers applied in the thermacare heatwrap rmp, effective 28sep2018, version 1.0.A site investigation was conducted on production records, a return sample was not received.A device malfunction was not identified during records review.There is no further investigation or actions needed.Follow-up (08jan2019): new information received from the product quality complaint group included investigational results.Follow-up (18mar2019): new information received from the product quality complaint group included: updated investigational results.This follow-up report is being submitted as a reportable malfunction mdr.Company clinical evaluation comment: based on the available information, the patient reported that the "wrapping had a tear, and it leaked onto her hand and had a "burn on her left middle finger." this is a single potential device malfunction which has a theoretical risk to cause skin burn.The company conducted an investigation, no device malfunction has been identified.No further investigations or actions is suggested at this time., comment: based on the available information, the patient reported that the "wrapping had a tear, and it leaked onto her hand and had a "burn on her left middle finger." this is a single potential device malfunction which has a theoretical risk to cause skin burn.The company conducted an investigation, no device malfunction has been identified.No further investigations or actions is suggested at this time.

• 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
• Manufacturer Contact: stella pietrafesa ; 235 e42nd street; new york, NY 10017
• MDR Report Key: 8487326
• MDR Text Key: 152045357
• Report Number: 1066015-2019-00087
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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