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

Lot Number AN2276

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 01/01/2020

Event Type  malfunction  

Event Description

Event verbatim [preferred term] one of the them was ripped apart and unsealed [device physical property issue], , narrative: this is a spontaneous report from a contactable consumer (patient).A patient of an unknown age and gender started to use thermacare heatwrap (thermacare lower back & hip) s/m, lot number an2276 and expiration date jan2022, on an unknown date (in 2020) for an unknown indication.Relevant medical history and concomitant medications were not provided.On (b)(6) 2020, the patient reported that he/she bought thermacare, he/she loved them but opened a new box and one of the them was ripped apart and unsealed (in 2020).He/she bought it 3 months before the report time (in 2020).The action taken with thermacare heatwrap in response to the event and the clinical outcome of the event were unknown at the time of the report.On 19dec2020, the product quality complaint group provided the following investigation results that yielded no product quality issues.Product: thermacare lower back & hip.Lot number: an2276.Expiration date: jan2022.Description of compliant: "one of the them was ripped apart and unsealed".Complaint sub-class: came apart/separated/torn (excludes damaged cells).Reasonably suggest device malfunction: yes.Severity of harm: s3.Site sample status: not received.Summary of investigation: batch an2276 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Batch/ process record review: review of the batch device history record for this batch concludes all release requirements were met.There are no known site investigations associated with this batch.Reserve sample evaluation: did not confirm reserved defect.Lot-specific trend identified: no.Expedite trend identified?: no.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).The return sample is not available at the site for evaluation, complaint cannot be confirmed.The plant has reviewed this batch from a manufacturing perspective.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.

Manufacturer Narrative

Product: thermacare lower back & hip.Lot number: an2276.Expiration date: jan2022.Description of compliant: "one of the them was ripped apart and unsealed".Complaint sub-class: came apart/separated/torn (excludes damaged cells).Reasonably suggest device malfunction: yes.Severity of harm: s3.Site sample status: not received.Summary of investigation: batch an2276 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Batch/ process record review: review of the batch device history record for this batch concludes all release requirements were met.There are no known site investigations associated with this batch.Reserve sample evaluation: did not confirm reserved defect.Lot-specific trend identified: no.Expedite trend identified?: no.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).The return sample is not available at the site for evaluation, complaint cannot be confirmed.The plant has reviewed this batch from a manufacturing perspective.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.

• 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: 11592703
• MDR Text Key: 280522385
• Report Number: 1066015-2021-00042
• 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: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2022
• Device Lot Number: AN2276
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1