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

Device Problem Temperature Problem (3022)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 11/23/2018

Event Type  Injury  

Event Description

Event verbatim [preferred term] was burned by it/ i had blisters on my right shoulder that night [burns second degree], frequency: every 8 hours.[device used for unapproved schedule].Case narrative: this is a spontaneous report from a contactable consumer via us fda.The regulatory authority report number is mw5081725.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare heatwraps multi-purpose joint pain) transdermal from (b)(6) 2018 every 8 hours for joint pain.Device was not available for evaluation.The patient medical history was not reported.The patient's concomitant medications were not reported.The patient was burned by thermacare heatwrap and had blisters on his/her right shoulder on the night of (b)(6) 2018.The action taken in response to the event for thermacare heatwrap was permanently withdrawn on (b)(6) 2018.The outcome of the event was not resolved.Fda considered the event "as burned by it, i had blisters on my right shoulder that night" as medically significant.No follow-up attempts are possible.No further information is expected.

Manufacturer Narrative

Investigation summary: the root cause category is non-assignable (complaint not confirmed).The product effect may vary with each individual.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.Batch and lot tested and found within specifications.Process related: n/a complaint confirmed: no design related: n/a, final confirmation status: not confirmed.

Event Description

Event verbatim [preferred term] was burned by it/ i had blisters on my right shoulder that night [burns second degree] , frequency: every 8 hours.[device used for unapproved schedule] ,.Case narrative:this is a spontaneous report from a contactable consumer via us fda.The regulatory authority report number is mw5081725.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare heatwraps multi-purpose joint pain) transdermal from (b)(6) 2018 every 8 hours for joint pain.Device was not available for evaluation.The patient medical history was not reported.The patient's concomitant medications were not reported.The patient was burned by thermacare heatwrap and had blisters on his/her right shoulder on the night of (b)(6) 2018.The action taken in response to the event for thermacare heatwrap was pemanently withdrawn on 06aug2018.The outcome of the event was not resolved.Fda considered the event "as burned by it, i had blisters on my right shoulder that night" as medically significant.As of 24jan2019, the product quality complaint (pqc) group investigation summary: the root cause category is non-assignable (complaint not confirmed).The product effect may vary with each individual.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.Batch and lot tested and found within specifications.Process related: n/a complaint confirmed: no design related: n/a, final confirmation status: not confirmed no follow-up attempts are possible.No further information is expected.Follow-up (24jan2019): new information received from the product quality complaint group included investigational results.No follow-up attempts are possible.No further information is expected.

• 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: 8195768
• MDR Text Key: 131481898
• Report Number: 1066015-2018-00207
• 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: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/26/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention