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

Device Problems Use of Device Problem (1670); Device Operates Differently Than Expected (2913)

Patient Problems Tissue Damage (2104); Discharge (2225); Inadequate Pain Relief (2388); Burn, Thermal (2530)

Event Date 11/01/2016

Event Type  Injury  

Event Description

Event verbatim [preferred term] burns [thermal burn] , open areas [open wounds] [wound] , open areas [open wounds] from which something strange came out [wound secretion].Case narrative:this is a spontaneous report from a contactable consumer or other non hcp.A (b)(6) female patient of an unspecified ethnicity started to use thermacare heatwrap (thermacare neck, shoulder & wrist) from an unspecified date for an unspecified indication.Medical history included ongoing glaucoma.The patient's concomitant medications were not reported.On an unspecified date, the patient reported she applied the heatwrap directly to the skin and experienced burns.She stated "suddenly there were open areas [open wounds] from which something strange came out." action taken with the suspect product was unknown.Therapeutic measures taken included bepanthen wound ointment and cortisone, but they did not help.Clinical outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the event " burns, suddenly there were open areas [open wounds] from which something strange came out" as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is assessed as associated with the use of the device.

Event Description

Burns [thermal burn] , open areas [open wounds] [wound] , open areas [open wounds] from which something strange came out [wound secretion] ,.Case narrative:this is a spontaneous report from a contactable consumer or other non hcp.A (b)(6) female patient of an unspecified ethnicity started to use thermacare heatwrap (thermacare neck, shoulder & wrist) from an unspecified date for an unspecified indication.Medical history included ongoing glaucoma.The patient's concomitant medications were not reported.On an unspecified date, the patient reported she applied the heatwrap directly to the skin and experienced burns.She stated "suddenly there were open areas [open wounds] from which something strange came out." action taken with the suspect product was unknown.Therapeutic measures taken included bepanthen wound ointment and cortisone, but they did not help.Clinical outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (13dec2016): same information was received via fda, fda regulatory authority number 1066015-2016-00160.Company clinical evaluation comment based on the information provided, the event " burns, suddenly there were open areas [open wounds] from which something strange came out" as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is assessed as associated with the use of the device., comment: based on the information provided, the event " burns, suddenly there were open areas [open wounds] from which something strange came out" as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is assessed as associated with the use of the device.

Event Description

Burns/ my skin, in the shoulder area was extensively reddened [thermal burn] , open areas [open wounds] [wound] , open areas [open wounds] from which something strange came out/ brown gelatinous mass came out [wound secretion] , patient slept for 2 hours while using the product/ applied the heatwrap directly to the skin [device use error] , heavy itching [pruritus] ,.Case narrative:this is a spontaneous report from a contactable consumer or other non hcp.A (b)(6) female patient of an unspecified race/ethnicity started to use thermacare heatwrap (thermacare neck, shoulder & wrist, expiration date: nov2016) in (b)(6) 2016 for lumbago / neck stiffness.Medical history included ongoing glaucoma.The patient previously used bengay (usa) and "horse cream".The patient's concomitant medication included tafluprost (taflotan sine).In (b)(6) 2016, the patient reported she applied the heatwrap directly to the skin, was asleep ("i slept for 2 hours") while using the product and experienced burns.She stated "suddenly there were open areas [open wounds] from which something strange came out." the patient also reported "my skin, in the shoulder area was extensively reddened with heavy itching and had 5-6 open wounds, from which brown gelatinous mass came out over a time of approximately 14 days.I have not used thermacare anymore in the neck.I treated the open areas with bepanthen healing ointment." action taken with the suspect product was permanently withdrawn.Therapeutic measures taken included bepanthen wound ointment and cortisone, but they did not help.No pharmacist or physician was contacted due to the events.Clinical outcome of the events was recovered on an unspecified date.The tone of the skin was described as bright to very bright.No skin disorder present.She only used one time for 8 hours.Thermacare has never been used before.Hot water bottles were used very often, with no complaints.No sport activities, no control of the skin, no reading of the leaflet during use of the product; no other medications have been taken, who could have led to adverse events.Additional information has been requested and will be provided as it becomes available.Follow-up (13dec2016): same information was received via fda, fda regulatory authority number 1066015-2016-00160.Follow-up (11jan2017): new information received from a contactable consumer included: patient details, drug history, product indication, dosage regimen, expiration date, action taken, concomitant medication, reaction data (additional events and description: wrong technique in device usage process, pruritus, and "my skin, in the shoulder area was extensively reddened") and events outcome.Follow-up attempts completed.No further information expected.Company clinical evaluation comment based on the information provided, the event " burns, suddenly there were open areas [open wounds] from which something strange came out" as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is assessed as associated with the use of the device., comment: based on the information provided, the event " burns, suddenly there were open areas [open wounds] from which something strange came out" as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is assessed as associated with the use of the device.

Manufacturer Narrative

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 adverse event safety request for investigation.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.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.Site sample status was not received.

Event Description

Event verbatim [preferred term] patient slept for 2 hours while using the product [device use error], burns/ my skin, in the shoulder area was extensively reddened [thermal burn], open areas [open wounds] [wound], open areas [open wounds] from which something strange came out/ brown gelatinous mass came out [wound secretion], heavy itching [pruritus], use thermacare neck, shoulder & wrist for lumbago [device use issue], , narrative: this is a spontaneous report from a contactable consumer.A 73-year-old female patient started to use thermacare heatwrap (thermacare neck, shoulder & wrist, expiration date: nov2016) in nov2016 for lumbago / neck stiffness.Medical history included ongoing glaucoma.The patient previously used bengay (usa) and "horse cream".The patient's concomitant medication included tafluprost (taflotan sine) for glaucoma.In (b)(6) 2016, the patient reported she applied the heatwrap directly to the skin, was asleep ("i slept for 2 hours") while using the product and experienced burns.She stated "suddenly there were open areas [open wounds] from which something strange came out." the patient also reported "my skin, in the shoulder area was extensively reddened with heavy itching and had 5-6 open wounds, from which brown gelatinous mass came out over a time of approximately 14 days.I have not used thermacare anymore in the neck.I treated the open areas with bepanthen healing ointment." the tone of the skin was described as bright to very bright.No skin disorder present.She only used one time for 8 hours.Thermacare has never been used before.Hot water bottles were used very often, with no complaints.No sport activities, no control of the skin, no reading of the leaflet during use of the product; no other medications have been taken, who could have led to adverse events.Action taken with the suspect product was permanently withdrawn.Therapeutic measures taken included bepanthen wound ointment and cortisone, but they did not help.No pharmacist or physician was contacted due to the events.Clinical outcome of the events was recovered on an unspecified date.Product investigation results are as follows: 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 adverse event safety request for investigation.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.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.Site sample status was not received.Follow-up (13dec2016): same information was received via fda.Follow-up (11jan2017): new information received from a contactable consumer included: patient details, drug history, product indication, dosage regimen, expiration date, action taken, concomitant medication, reaction data (additional events and description: wrong technique in device usage process, pruritus, and "my skin, in the shoulder area was extensively reddened") and events outcome.Follow-up attempts completed.No further information expected.Follow-up (21may2020): this is a follow-up spontaneou report from a product quality complaint group includes product investigation results and event "use thermacare neck, shoulder & wrist for lumbago" added.No follow up attempts possible.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: 6150995
• MDR Text Key: 61623772
• Report Number: 1066015-2016-00160
• 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,Followup,Followup
• Report Date: 11/30/2016

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
• Device Expiration Date: 11/01/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/03/2017; 01/17/2017; 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TAFLOTAN SINE [DOSAGE FORM:]
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 58