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

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This investigation was conducted for an unknown lot number lower back/hip (lbh) product.The root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass cells damaged/leaking.The 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.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.The sample had not been received by the site.Severity of harm: s3.There is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per rpt- 38832 hazard analysis thermacare heat wrap product: 8 and 12 hour.

Event Description

Opened the package and the wrap was damaged [device leakage] ,.Case narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip) from an unspecified date for an unspecified indication.The patient medical history was not reported.The patient's concomitant medications were not reported.The patient opened the package and the wrap was damaged.There were tears in 2 of the cells with the charcoal spilling out.She had photos.The action taken in response to the event was unknown.The outcome of the event was unknown.According to the product quality complaint group on (b)(6) 2020: this investigation was conducted for an unknown lot number lower back/hip (lbh) product.The root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass cells damaged/leaking.The 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.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.The sample had not been received by the site.Severity of harm: s3.There is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per rpt- 38832 hazard analysis thermacare heat wrap product: 8 and 12 hour., comment: the patient reported that the "opened the package and the wrap was damaged.There were tears in 2 of the cells with the charcoal spilling out".No adverse event was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.The event is assessed as associated with use of device.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time.

• 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
• Manufacturer Contact: stella pietrafesa ; 235 e42nd street; new york, NY 10017
• MDR Report Key: 9836710
• MDR Text Key: 191136130
• Report Number: 1066015-2020-00077
• 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: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: No
• 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