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

Device Problem Loss of or Failure to Bond (1068)

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

Event Type  malfunction  

Event Description

Subpar product where the glue holding the cloth-like material has failed rendering the heatwrap unusable.[device issue] ,.Case narrative:this is a spontaneous report from a contactable consumer.A male patient of an unspecified age started to receive thermacare heatwrap (robax lower back & hip heatwrap), lot number not reported, expiration date oct2021, from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient experienced subpar product where the glue holding the cloth-like material has failed rendering the heatwrap unusable on an unspecified date.The action taken with thermacare heatwrap is unknown.The outcome of the event was unknown.Follow-up (b)(6) 2019): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment: based on available information, the patient reported "subpar product where the glue holding the cloth-like material has failed rendering the heatwrap unusable", which represents a potential device malfunction.There was no adverse reaction such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.The event is medically assessed as associated with the use of the device., comment: based on available information, the patient reported "subpar product where the glue holding the cloth-like material has failed rendering the heatwrap unusable", which represents a potential device malfunction.There was no adverse reaction such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.The event is medically assessed as associated with the use of the device.

Manufacturer Narrative

Conclusion: 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 came apart/separated/torn (excludes damaged cells).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.

Event Description

Subpar product where the glue holding the cloth-like material has failed rendering the heatwrap unusable.[no adverse event].Case description: this case has been considered invalid since there is no indication that the consumer experienced an event under product thermacare, just product complaint.This is a spontaneous report from a contactable consumer.A male patient of an unspecified age started to receive thermacare heatwrap (robax lower back & hip heatwrap), lot number not reported, expiration date oct2021, from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient experienced subpar product where the glue holding the cloth-like material has failed rendering the heatwrap unusable on an unspecified date.The action taken with thermacare heatwrap was unknown.The outcome of the event was unknown.According to the product quality complaint group: severity of harm was s1.Conclusion: 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 came apart/separated/torn (excludes damaged cells).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.Follow-up (12may2019): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (27aug2019): new information received from the product quality complaint group includes investigational results and severity rating and case downgrade to invalid.No follow-up attempts possible.No further information expected.

• Brand Name: ROBAX LOWER BACK & HIP HEATWRAP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 9261084
• MDR Text Key: 196295498
• Report Number: 1066015-2019-00427
• 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,foreign
• Type of Report: Initial,Followup
• Report Date: 05/12/2019

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: 10/01/2021
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2019
• Supplement Dates Manufacturer Received: 08/27/2019
• Supplement Dates FDA Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1