MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE LOWER BACK & HIP; DISPOSABLE PACK, HOT

Lot Number X79742

Device Problem Unintended Ejection (1234)

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

Event Type  malfunction  

Event Description

The heat wraps were wet in the package and hence could not be used [device leakage] ,.Case narrative:this is a spontaneous report from a contactable pharmacist regarding thermacare heatwrap (thermacare lower back & hip) 8 hr, device lot number x79742, expiration date nov2021.The pharmacist reported heat wraps were wet in the package and hence could not be used on an unspecified date.The action taken and outcome was not provided.No follow-up attempts are needed.No further information is expected.Company clinical evaluation comment: the reported device issue of "heat wraps were wet in the package" coded as device leakage did not cause serious injury in the patient.This is a single potential device malfunction which has a theoretical risk to cause serious injury to patient and result in deterioration in state of health of the patient, if it were to recur., comment: the reported device issue of "heat wraps were wet in the package" coded as device leakage did not cause serious injury in the patient.This is a single potential device malfunction which has a theoretical risk to cause serious injury to patient and result in deterioration in state of health of the patient, if it were to recur.

Event Description

Event verbatim [preferred term] the heat wraps were wet in the package and hence could not be used [device leakage] , case narrative:this is a spontaneous report from a contactable pharmacist regarding thermacare heatwrap (thermacare lower back & hip) 8 hr, device lot number x79742, expiration date nov2021.The pharmacist reported heat wraps were wet in the package and hence could not be used on an unspecified date.The action taken and outcome was not provided.No follow-up attempts are needed.No further information is expected.Follow-up (24feb2020): this follow-up is being submitted to notify that the investigation is still ongoing.Company clinical evaluation comment: the reported device issue of "heat wraps were wet in the package" coded as device leakage did not cause serious injury in the patient.This is a single potential device malfunction which has a theoretical risk to cause serious injury to patient and result in deterioration in state of health of the patient, if it were to recur., comment: the reported device issue of "heat wraps were wet in the package" coded as device leakage did not cause serious injury in the patient.This is a single potential device malfunction which has a theoretical risk to cause serious injury to patient and result in deterioration in state of health of the patient, if it were to recur.

Event Description

Event verbatim [preferred term] the heat wraps were wet in the package and hence could not be used [no adverse event] ,.Case narrative:this is a spontaneous report from a contactable pharmacist regarding thermacare heatwrap (thermacare lower back & hip) 8 hr, device lot number x79742, expiration date nov2021.The pharmacist reported heat wraps were wet in the package and hence could not be used on an unspecified date.The action taken and outcome was not provided.The product quality group reported that: the root cause category is non assignable (complaint not confirmed as a quality defect).Sample is not available for evaluation by the site; complaint cannot be confirmed.The cause of wet/damp/too soft/sticky/melted/leaking/stuck together/stuck to packaging is inconclusive after review of device history records.Review of records does not provide evidence to support defective product.In general, as wraps heat up and cool, condensation (moisture/water droplets) occurs.A small pouch leak can cause the wrap to prematurely heat up inside the wrapper, which subsequently cools, and produces condensation inside the pouch which was noted by the consumer.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of the 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.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.No follow-up attempts are needed.No further information is expected.Follow-up (24feb2020): this follow-up is being submitted to notify that the investigation is still ongoing.Follow-up (04mar2020): new information received from the product quality group includes: investigational results which include that this is not a cell leakage but rather a "small pouch leak can cause the wrap to prematurely heat: the consumer did not state the wrap leaked.This case is now considered invalid as there is only a product complaint.No follow-up attempts are needed.No further information is expected.

Manufacturer Narrative

The root cause category is non assignable (complaint not confirmed as a quality defect).Sample is not available for evaluation by the site; complaint cannot be confirmed.The cause of wet/damp/too soft/sticky/melted/leaking/stuck together/stuck to packaging is inconclusive after review of device history records.Review of records does not provide evidence to support defective product.In general, as wraps heat up and cool, condensation (moisture/water droplets) occurs.A small pouch leak can cause the wrap to prematurely heat up inside the wrapper, which subsequently cools, and produces condensation inside the pouch which was noted by the consumer.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of the 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.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.

• Brand Name: THERMACARE LOWER BACK & HIP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 9519725
• MDR Text Key: 191425629
• Report Number: 1066015-2019-00557
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2019

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: Health Professional
• Device Expiration Date: 11/01/2021
• Device Lot Number: X79742
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/26/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/03/2020; 03/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1