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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Rash (2033); Urticaria (2278)

Event Date 03/12/2017

Event Type  Injury  

Event Description

Rash/burn turned out to be the beginning of shingles [herpes zoster], did not check skin under the product while wearing thermacare/the patient did read the instructions to know how long to wear the heatwrap [intentional device misuse], hives on arms, hands, legs, belly [urticaria].Case narrative: this is a spontaneous report from a contactable consumer.A (b)(6) female patient (not pregnant) started to use thermacare heatwrap (thermacare lower back & hip) on (b)(6) 2017 for pain in lower back right side.The patient's medical history was not reported.The patient's concomitant medications were none.The patient previously used thermacare heatwrap for unknown indication with no issues.On (b)(6) 2017, the patient reported "what do i need to put on a rash/burn from this wrap? are there any directions for care in case of burn/rash? the package & all has already gone out in our trash.It was a size small lower back/hip band.I didn't even think to save it for you for testing".The patient used the heatwrap for 3 hours and did not check the skin under the heatwrap while wearing on (b)(6) 2017.When she removed it, it left large red burn/rash marks.The patient took a shower to try to clean off whatever may have caused it, but was not hospitalized and did not receive any treatment in response to the event burn/rash.Upon follow-up received on (b)(6) 2017, the patient reported the rash/burn turned out to be the beginning of shingles on (b)(6) 2017.The patient was hospitalized on an unspecified date in 2017 in response to the event shingles and treatment included tylenol for pain.The patient reported experiencing "hives randomly" occurring 1-2 times daily on arms, hands, legs, and belly since (b)(6) 2017.Treatment for hives included allergy 24 hr and benadryl cream.The patient described skin tone as very light or fair, no sensitive skin or abnormal skin conditions.She did not engage in exercise while using the product and did not take any medication during the time the problem/symptom was experienced.The patient did read the instructions to know how long to wear the heatwrap.Action taken for the product was permanently withdrawn.Clinical outcome of hives is not resolved.The outcome of the other events is unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (24-apr-2017): new information received from a contactable consumer includes: suspect product indication and reaction data (additional event of shingles).Follow-up (15-may-2017): new information from a contactable consumer includes: patient details, past product use, product dosage regimen, action taken, event onset and stop dates, hospitalization required for shingles, therapeutic measures, additional events (hives and device use error) and event outcome.Follow-up (31-may-2017).New information received from a contactable consumer included: deny of concomitant medications.Follow up attempts completed.No further information is expected.Follow-up (28-oct-2019): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment: based on the information provided, the event "rash/burn turned out to be the beginning of shingles" with hospitalization and "intentional device misuse" as described in this case are considered as serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event "hive" is non-serious.The events are assessed as associated with the use of the device.Comment: based on the information provided, the event "rash/burn turned out to be the beginning of shingles" with hospitalization and "intentional device misuse" as described in this case are considered as serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event "hive" is non-serious.The events are assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term] rash/burn turned out to be the beginning of shingles [herpes zoster] , did not check skin under the product while wearing thermacare/the patient did read the instructions to know how long to wear the heatwrap [intentional device misuse] , hives; on arms, hands, legs, belly [urticaria].Case narrative:this is a spontaneous report from a contactable consumer.A 38-year-old female patient (not pregnant) started to use thermacare heatwrap (thermacare lower back & hip) on (b)(6)2017 for pain in lower back right side.The patient's medical history was not reported.The patient's concomitant medications were none.The patient previously used thermacare heatwrap for unknown indication with no issues.On (b)(6)2017, the patient reported "what do i need to put on a rash/burn from this wrap? are there any directions for care in case of burn/rash? the package & all has already gone out in our trash.It was a size small lower back/hip band.I didn't even think to save it for you for testing".The patient used the heatwrap for 3 hours and did not check the skin under the heatwrap while wearing on (b)(6)2017.When she removed it, it left large red burn/rash marks.The patient took a shower to try to clean off whatever may have caused it, but was not hospitalized and did not receive any treatment in response to the event burn/rash.Upon follow-up received on 24apr2017, the patient reported the rash/burn turned out to be the beginning of shingles on (b)(6)2017.The patient was hospitalized on an unspecified date in 2017 in response to the event shingles and treatment included tylenol for pain.The patient reported experiencing "hives randomly" occurring 1-2 times daily on arms, hands, legs, and belly since (b)(6)2017.Treatment for hives included allergy 24hr and benadryl cream.The patient described skin tone as very light or fair, no sensitive skin or abnormal skin conditions.She did not engage in exercise while using the product and did not take any medication during the time the problem/symptom was experienced.The patient did read the instructions to know how long to wear the heatwrap.Action taken for the product was permanently withdrawn.Clinical outcome of hives is not resolved.The outcome of the other events is unknown.Product quality complaints provided the following investigation results: the sample status at the site was not received.This investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.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.There was no reasonable suggestion of device malfunction.Follow-up (24apr2017): new information received from a contactable consumer includes: suspect product indication and reaction data (additional event of shingles).Follow-up (15may2017): new information from a contactable consumer includes: patient details, past product use, product dosage regimen, action taken, event onset and stop dates, hospitalization required for shingles, therapeutic measures, additional events (hives and device use error) and event outcome.Follow up (31may2017).New information received from a contactable consumer included: deny of concomitant medications.Follow up attempts completed.No further information is expected.Follow-up (28oct2019): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (19mar2020): new information received from a product quality complaint group includes: investigation results.Follow up attempts completed.No further information is expected.Comment: based on the information provided, the event "rash/burn turned out to be the beginning of shingles" with hospitalization and "intentional device misuse" as described in this case are considered as serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event "hive" is non-serious.The events are assessed as associated with the use of the device.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.Product effect varies with each individual.In the case narrative, there is evidence of "intentional device misuse" which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time.

Manufacturer Narrative

The sample status at the site was not received.This investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.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.There was no reasonable suggestion of device malfunction.

• Brand Name: THERMACARE LOWER BACK & HIP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 9387932
• MDR Text Key: 185300837
• Report Number: 1066015-2019-00502
• 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: 03/15/2017

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?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/27/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 38 YR
• Patient Weight: 63