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

Device Problems Failure To Adhere Or Bond (1031); Material Disintegration (1177); Material Separation (1562); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Rash (2033); Tissue Damage (2104)

Event Date 03/03/2017

Event Type  Injury  

Event Description

Event verbatim [preferred term] damage to her skin [skin disorder]; the backing came away separately, leaving the adhesive side still stuck to her leg/wrap disintegrated during use/had to literally scrape the adhesive off my skin [device adhesion issue]; left red marks on leg [erythema]; there is still discoloration weeks later [skin discolouration]; the adhesive has left a rash on her leg 5 days later [rash].Case narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age and ethnicity started to use thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain) from an unspecified date daily for a pulled muscle.The patient's medical history and concomitant medications were not reported.On (b)(6) 2017, the patient reported the adhesive tabs disintegrated, falling apart during use, and left red marks and a rash on her leg where the adhesive had been.The backing came away separately, leaving the adhesive side still stuck to her leg and it had to be peeled off in little pieces like sunburn.She stated she literally had to scrape the adhesive off her skin.There is still discoloration weeks later.The patient mentioned she used the heatwrap as directed.She was concerned the faulty product has done damage to her skin in some way.Action taken with the suspect product was unknown.Clinical outcome of the events was not resolved.Additional information has been requested and will be provided as it becomes available.Follow-up (31mar2017): new information received from a contactable consumer via us fda with regulatory authority report number: (report number: mw5068571) includes: suspect product indication, reaction data (additional events of erythema and skin discoloration), event onset date and event outcome.Us fda considered this case as serious for 'serious injury'.Case upgraded to serious and reportable.

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 package.Reasonably suggest device malfunction: yes.Severity of harm: s1.Site sample status was not received.

Event Description

Event verbatim [preferred term].Damage to her skin [skin disorder], the backing came away separately, leaving the adhesive side still stuck to her leg/wrap disintegrated during use/had to literally scrape the adhesive off my skin [device adhesion issue], left red marks on leg [erythema], there is still discoloration weeks later [skin discolouration], the adhesive has left a rash on her leg 5 days later [rash].Narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age and ethnicity started to use thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain) from an unspecified date daily for a pulled muscle.The patient's medical history and concomitant medications were not reported.On (b)(6) 2017, the patient reported the adhesive tabs disintegrated, falling apart during use, and left red marks and a rash on her leg where the adhesive had been.The backing came away separately, leaving the adhesive side still stuck to her leg and it had to be peeled off in little pieces like sunburn.She stated she literally had to scrape the adhesive off her skin.There is still discoloration weeks later.The patient mentioned she used the heatwrap as directed.She was concerned the faulty product has done damage to her skin in some way.Action taken with the suspect product was unknown.Clinical outcome of the events was not resolved.Product investigation results were as follows: 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 package.Reasonably suggest device malfunction: yes.Severity of harm: s1.Site sample status was not received.Follow-up (31mar2017): new information received from a contactable consumer via us fda with regulatory authority report number: (report number: mw5068571) includes: suspect product indication, reaction data (additional events of erythema and skin discoloration), event onset date and event outcome.Us fda considered this case as serious for 'serious injury'.Case upgraded to serious and reportable.Follow-up (20may2017): follow-up attempts are completed.No further information is expected.Follow-up (21jul2020): new information received from a product quality complaint group includes product investigation results.Follow-up attempts are completed.No further information is expected.

• Brand Name: THERMACARE HEATWRAPS MULTI-PURPOSE MUSCLE PAIN
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 6473108
• MDR Text Key: 72176414
• Report Number: 1066015-2017-00074
• 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: 03/03/2017

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?: Yes
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/07/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention