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

Lot Number T26686

Device Problems Break (1069); Gel Leak (1267); Nonstandard Device (1420)

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

Event Type  malfunction  

Manufacturer Narrative

Investigation (b)(4); t26691, t26693, t26686 & s68516 menstrual & muscle joint us cells damaged/leaking was conducted for the same sub-class.This batch t26686 was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516) per investigation (b)(4).

Event Description

Event verbatim [preferred term] broken heat cell/ it was leaking after she took it off [device leakage] , broken heat cell/ it was leaking after she took it off/ skin did have contact with the heat cell contents [accidental exposure to product] , covered wrap with another heating pad like device [device use error] ,.Case narrative:this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to use thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number t26686, expiration date jul2020) from (b)(6) 2018 for shoulder pain.The patient's medical history was not reported.There were no concomitant medications.On (b)(6) 2018, the patient reported she had covered the thermacare heatwrap during use with another heating pad-like product for a brief time that was turned on.She stated when she removed the heatwrap, she noticed there was a broken heat cell on the heatwrap.The patient's skin did have contact with the heat cell contents when she went to brush it off of her bed where she had laid the heatwrap down.She was not entirely sure if the actual heat cell contents came in contact with her shoulder, but she did notice it was leaking after she took it off.The patient had thrown the suspect product away.Action taken with the suspect product was unknown.Clinical outcome of the events was unknown.According to the product quality complaint group: investigation summary: the root cause category is non-assignable (complaint not confirmed).The wrap has not been received at the site for evaluation, the complaint cannot be confirmed.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.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.Process related: no.Design related: no.Final confirmation status: not confirmed.According to the product quality complaint group on (b)(6) 2018: investigation (b)(4) : t26691, t26693, t26686 & s68516 menstrual & muscle joint us cells damaged/leaking was conducted for the same sub-class.This batch t26686 was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516) per investigation (b)(4).Additional information has been requested and will be provided as it becomes available.Follow-up (29mar2018): new information received from the product quality complaint group included investigational results.Follow-up (15oct2018): new information received from the product quality complaint group included revised investigational results.Company clinical evaluation comment: based on the information provided, the events device leakage, accidental exposure to product and device use error are medically assessed as non-serious and associated with the use of the device.The above referenced lot number t26686 was recalled on 02oct2018.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall of 6 lots [s68516, t26686, t26691, t26693, 8054ha, 8054hb] due to a potential for device leakage of the ingredients contained in the heat wrap that could result in serious skin-related events, including burn.These 6 lots were distributed in the united states with expiry dates of either july or august 2020.Comment: based on the information provided, the events device leakage, accidental exposure to product and device use error are medically assessed as non-serious and associated with the use of the device.The above referenced lot number t26686 was recalled on 02oct2018.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall of 6 lots [s68516, t26686, t26691, t26693, 8054ha, 8054hb] due to a potential for device leakage of the ingredients contained in the heat wrap that could result in serious skin-related events, including burn.These 6 lots were distributed in the united states with expiry dates of either july or august 2020.

• 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: b green ; 235 e42nd street; new york, NY 10017
• MDR Report Key: 8060624
• MDR Text Key: 129349953
• Report Number: 1066015-2018-00151
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/13/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2020
• Device Lot Number: T26686
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/12/2018
• 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