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

Device Problems Loss of or Failure to Bond (1068); Material Deformation (2976)

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

Event Type  malfunction  

Event Description

Event verbatim [preferred term].Tried to get it to stick it got a hole in it [device breakage], it did not stick [device adhesion issue], narrative: this is a spontaneous report from a non-contactable consumer.A patient of unspecified age and gender received thermacare heatwrap (thermacare neck, shoulder & wrist), from an unspecified date for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient had the thermacare neck heat wrap, it did not stick and when the patient tried to get it to stick it got a hole in it on an unspecified date.The patient threw the product away.Action taken with the thermacare heatwrap was unknown.The outcome of the event was unknown.Additional information has been requested and will be provided as it becomes available.

Event Description

Event verbatim [preferred term] tried to get it to stick it got a hole in it [device breakage], it did not stick [device adhesion issue], , narrative: this case is invalid due to being the non-retained duplicate of 2021218577.This is a spontaneous report from a non-contactable consumer.A patient of unspecified age and gender received thermacare heatwrap (thermacare neck, shoulder & wrist), from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient had the thermacare neck heat wrap, it did not stick and when the patient tried to get it to stick it got a hole in it on an unspecified date.The patient threw the product away.Action taken with the thermacare heatwrap was unknown.The outcome of the event was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (25mar2021): this case is being deleted from the database for the following reason: duplicate case.This is a follow-up report to notify that cases (b)(4) and (b)(4) are duplicates.All subsequent follow-up information will be reported under manufacturer report number (b)(4).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: 11555529
• MDR Text Key: 266398577
• Report Number: 1066015-2021-00037
• 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,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1