MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE KNEE & ELBOW; DISPOSABLE PACK, HOT

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: the root cause category is non-assignable (complaint not confirmed).The sample is not available from consumer for evaluation by the site, the complaint cannot be 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.

Event Description

Event verbatim [preferred term] pc: nothing inside either box except for what looks like coffee grounds/ no wraps or anything except coffee grounds [device leakage] ,.Case narrative:this is a spontaneous report from a contactable consumer.This (b)(6) female consumer started to receive thermacare heatwrap (thermacare knee & elbow) expiration date: dec2018, from unknown date for arthritis.Medical history included arthritis, macular degeneration, and pain in her legs.Concomitant medication was not reported.Consumer purchased two different boxes of thermacare heatwraps, each box was supposed to contain 6 wraps.There was nothing inside either box except for what looks like coffee grounds, no wraps or anything except coffee grounds.She took a picture of the boxes.Consumer had pain in her legs.She had this before ever using the product.She has arthritis and uses the product for this.She also has macular degeneration.She confirmed she was diagnosed with arthritis and macular degeneration before using the product.Device was available for evaluation.According to product quality complaint group: investigation summary: the root cause category is non-assignable (complaint not confirmed).The sample is not available from consumer for evaluation by the site, the complaint cannot be 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.Follow-up (17dec2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment the event "nothing inside either box except for what looked like coffee grounds" (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device., comment: the event "nothing inside either box except for what looked like coffee grounds" (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device.

• Brand Name: THERMACARE KNEE & ELBOW
• 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: 9260910
• MDR Text Key: 220265619
• Report Number: 1066015-2019-00331
• 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: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/01/2018
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2019
• 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
• Patient Age: 78 YR