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

Lot Number DK2617

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The root cause category is non assignable (complaint not confirmed as a quality defect).The return sample is not available from consumer for evaluation the complaint can not 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.

Event Description

When i put them up the heat cells came apart.There was a black stuff coming out [device leakage], narrative: this is a spontaneous report from a contactable consumer (patient).A patient of unspecified age and gender received thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number dk2617, expiration date 28feb2023, date of manufacture 06mar2020, via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient reported regarding heatwraps when the patient put them up the heat cells came apart.There was a black stuff coming out on an unspecified date.It was the neck pain therapy there was 3 in a package and it happened to 2 of the wraps.The action taken in response to the event of the product was unknown.The outcome of the event was unknown.According to product quality complaint group, the root cause category is non assignable (complaint not confirmed as a quality defect).The return sample is not available from consumer for evaluation the complaint can not 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.No follow-up attempts are needed.No further information is expected.

• 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
• MDR Report Key: 11526667
• MDR Text Key: 280508559
• Report Number: 1066015-2021-00035
• 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: consumer
• Type of Report: Initial
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2023
• Device Lot Number: DK2617
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1