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

Lot Number Q01104

Device Problems Break (1069); Leak/Splash (1354)

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

Event Type  malfunction  

Manufacturer Narrative

The root cause category is non-assignable (complaint not confirmed).The sample is not available from consumer for evaluation by the site, 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.The corrective and preventative actions (capa) implemented for the previous confirmed complaints of cells damaged/leaking have been effective, since no complaints have been confirmed on the m line involving neck, shoulder, wrist products since capa was completed.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

One of the heat wraps had abnormal black stains [device leakage].Case narrative:this is a spontaneous report from a contactable pharmacist.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number q01104, expiration date jun2019, via an unspecified area of administration, from an unspecified date, for an unspecified indication.Medical history and concomitant medications were not reported.It was reported that one of the heat wraps had abnormal black stains on an unspecified date.The action taken with thermacare heatwrap and the outcome of the event was unknown.The product quality group reported that: the root cause category is non-assignable (complaint not confirmed).The sample is not available from consumer for evaluation by the site, the complaint cannot 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.The corrective and preventative actions (capa) implemented for the previous confirmed complaints of cells damaged/leaking have been effective, since no complaints have been confirmed on the m line involving neck, shoulder, wrist products since capa was completed.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.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: the event "one of the heat wraps had abnormal black stains " (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device.Comment: the event "one of the heat wraps had abnormal black stains " (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device.

Manufacturer Narrative

The root cause category is non-assignable (complaint not confirmed).The sample is not available from consumer for evaluation by the site, 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.The corrective and preventative actions (capa) implemented for the previous confirmed complaints of cells damaged/leaking have been effective, since no complaints have been confirmed on the m line involving neck, shoulder, wrist products since capa was completed.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

Event verbatim [preferred term] one of the heat wraps had abnormal black stains [device leakage] ,.Case narrative:this is a spontaneous report from a contactable pharmacist.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number q01104, expiration date jun2019, via an unspecified area of administration, from an unspecified date, for an unspecified indication.Medical history and concomitant medications were not reported.It was reported that one of the heat wraps had abnormal black stains on an unspecified date.The action taken with thermacare heatwrap and the outcome of the event was unknown.The product quality group reported that: the root cause category is non-assignable (complaint not confirmed).The sample is not available from consumer for evaluation by the site, the complaint cannot 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.The corrective and preventative actions (capa) implemented for the previous confirmed complaints of cells damaged/leaking have been effective, since no complaints have been confirmed on the m line involving neck, shoulder, wrist products since capa was completed.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.Follow-up (16dec2019): this follow-up report is being submitted as a final reportable mdr., comment: the event "one of the heat wraps had abnormal black stains " (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.

• 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: 9263350
• MDR Text Key: 220010583
• Report Number: 1066015-2019-00457
• 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
• Report Date: 10/19/2017

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: Lay User/Patient
• Device Expiration Date: 06/01/2019
• Device Lot Number: Q01104
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1