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

Lot Number EC2278

Device Problems Leak/Splash (1354); Material Deformation (2976)

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

Event Type  malfunction  

Event Description

Leakage in a heatwrap from a box [device leakage].Narrative: this is a spontaneous report from a contactable consumer.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare heatwraps multi-purpose joint pain), device lot number ec2278, expiration date 30jun2023, upc number: (b)(4).From an unspecified date for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient reported leakage in a heatwrap from a box of advanced joint pain therapy wraps.She didn't know whether it was safe to use the remaining wraps.The action taken in response to the event was unknown.The event outcome was unknown.Additional information has been requested and will be provided as it becomes available.

Event Description

Event verbatim [preferred term]: leakage in a heatwrap from a box [device leakage].Narrative: this is a spontaneous report from a contactable consumer.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare heatwraps multi-purpose joint pain), device lot number ec2278, expiration date 30jun2023, upc number: 305733017258 from an unspecified date for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient reported leakage in a heatwrap from a box of advanced joint pain therapy wraps.She didn't know whether it was safe to use the remaining wraps.The sample was available to be returned for evaluation.The action taken in response to the event was unknown.The event outcome was unknown.According to product quality complaint group, 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.The site investigation is in process.Additional information has been requested and will be provided as it becomes available.Follow-up (17jan2021 and 20jan2021): new information received from a contactable consumer and from a product quality complaint group included: sample available to be returned and severity of harm.

Event Description

Event verbatim [preferred term] leakage in a heatwrap from a box [device leakage], , narrative: this is a spontaneous report from a contactable consumer.A patient of unspecified age and gender started to use thermacare heatwrap (thermacare heatwraps multi-purpose joint pain) (device lot number ec2278, expiration date jun2023, upc number: 305733017258) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient reported leakage in a heatwrap from a box of advanced joint pain therapy wraps.The patient didn't know whether it was safe to use the remaining wraps.The sample was available to be returned for evaluation.Action taken in response to the event was unknown.The 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 as a quality defect).The return sample evaluation shows no cell damage or leaks present on the wraps.The cell packs are intact; no chemistry is leaking from the cells.No further action is required.Our 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.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks 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.An evaluation of the complaint history confirms that this is the first complaint for the sub class heat cells damaged/leaking received at the (name) site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend.On the basis of this evaluation, a trend does not exist for this batch.Return sample evaluation: 5 wraps- one wrap shows evidence of wear.No obvious defects- no cell damage or leaks.No stray chemistry.Four wraps are inside sealed pouches.Opened pouches to inspect wraps.No obvious defects to wraps.Reasonably suggest device malfunction?: yes.Severity of harm: s3.Site sample status: received at the site.Follow-up (17jan2021 and 20jan2021): new information received from a contactable consumer and from a product quality complaint group included: sample available to be returned and severity of harm.Follow-up (09feb2021): new information received from product quality complaints (pqc) group included: product quality investigation results.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).The return sample evaluation shows no cell damage or leaks present on the wraps.The cell packs are intact; no chemistry is leaking from the cells.No further action is required.Our 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.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks 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.An evaluation of the complaint history confirms that this is the first complaint for the sub class heat cells damaged/leaking received at the (name) site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend.On the basis of this evaluation, a trend does not exist for this batch.Return sample evaluation: 5 wraps- one wrap shows evidence of wear.No obvious defects- no cell damage or leaks.No stray chemistry.Four wraps are inside sealed pouches.Opened pouches to inspect wraps.No obvious defects to wraps.Reasonably suggest device malfunction?: yes.Severity of harm: s3.Site sample status: received at the site.

• Brand Name: THERMACARE HEATWRAPS MULTI-PURPOSE JOINT PAIN
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 11245950
• MDR Text Key: 230225387
• Report Number: 1066015-2021-00013
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733017258
• UDI-Public: 305733017258
• 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,Followup,Followup
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/01/2023
• Device Lot Number: EC2278
• Was Device Available for Evaluation?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1