MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAPS MULTI-PURPOSE MUSCLE PAIN; DISPOSABLE PACK, HOT

Lot Number S68516

Device Problem Nonstandard Device (1420)

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

Event Type  malfunction  

Manufacturer Narrative

The root cause category is non assignable (complaint not confirmed).There is not a product quality complaint associated with this complaint, consumer stated that "they did not leak".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.T26691, t26693, t26686 & s68516 menstrual & muscle joint us cells damaged/leaking was conducted for the sub-class of cells damaged/leaking.This batch s68516 was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516).This current complaint does not involve cell pack damage/leaking.

Event Description

Event verbatim [preferred term] i think they leaked when my husband used them.Consumer then went back and stated they did not leak [device leakage].Case narrative: this is a spontaneous report from a contactable consumer reporting on behalf of her husband.This male patient of an unspecified age started to use thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain) (device lot number s68516, expiration date jul2020) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient reported "i have some of your recalled products.I have the muscle pain therapy heatwraps.I have 3 boxes.I think they leaked when my husband used them." consumer then went back and stated they did not leak.Action taken with the suspect product was unknown.Clinical outcome of the event was unknown.Additional information received from product quality complaint (pqc) group included investigation results.The root cause category is non assignable (complaint not confirmed).There is not a product quality complaint associated with this complaint, consumer stated that "they did not leak".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.T26691, t26693, t26686 & s68516 menstrual & muscle joint us cells damaged/leaking was conducted for the sub-class of cells damaged/leaking.This batch s68516 was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516).This current complaint does not involve cell pack damage/leaking.Follow-up (28dec2018): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up (29nov2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment: the above referenced lot number s68516 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: the above referenced lot number s68516 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 HEATWRAPS MULTI-PURPOSE MUSCLE PAIN
• 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: 9260675
• MDR Text Key: 220060260
• Report Number: 1066015-2019-00467
• 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: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2020
• Device Lot Number: S68516
• 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