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

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problems Erythema (1840); Itching Sensation (1943); Pain (1994); Rupture (2208); Fluid Discharge (2686); Partial thickness (Second Degree) Burn (2694)

Event Date 01/01/2015

Event Type  Injury  

Event Description

Large burn blister and surrounding red area itching [burns second degree].Blister broke [blister rupture].Blister broke, lots of fluid [wound secretion].Used heatwrap for leg cramps, used heatwrap overnight while sleeping [device misuse].Ended up with large blister and surrounding red area itching [pruritus] scab [scab].Case description: this is a spontaneous report from a non-clinical-study program, (b)(4) - general company information.A contactable consumer reported a (b)(6)-year-old female patient of an unspecified ethnicity started to receive thermacare heatwrap (thermacare lower back & hip) from an unspecified date in (b)(6) 2015 for leg cramps.The patient's medical history was not reported.Concomitant medications were reported as none.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date in 2009 for an unspecified indication with no adverse effect.On an unspecified date in (b)(6) 2015, the patient reported she used the heatwrap overnight while sleeping for approximately 4 hours over her pajamas on her left calf.She stated she awoke and attempted to scratch her calf and felt a large blister.The patient got a mirror to look and noted a large burn blister about 1 inch in size and a very sore area around the burn blister about 2x2 inches in size, very red and itching.She mentioned the pain was pretty deep into her calf.After 4 days, the patient reported "blister broke, lots of fluid, used band aid to keep clean, still sore and itching.After blister broke left a pretty deep hole and no scab.Three weeks later still no scab but still pain and itching.I was getting worried about the open wound on my leg i kept it covered with 2 band aids and neosporin, still didn't heal, decided neosporin was stopping the forming of scab, so wiped it clean and just left band aids.10 days later it started to heal, scabbed over (but still itching and red around scab) but smaller area.Last scab fill of 1st week of (b)(6), still some redness little to none itching." the patient assessed her skin tone as medium.She denied having sensitive skin or any skin abnormal skin conditions.The patient previously used other heat products for pain relief years ago without any adverse effect.She read the usage instructions prior to heatwrap usage.The patient mentioned action taken with the product was continued.Therapeutic measures taken included neosporin and band aids.No hospitalization was required as a result of the events.Clinical outcome of the events was resolving.Additional information has been requested and will be provided as it becomes available.Follow-up (19oct2015): new information received from a contactable consumer includes: patient details, updated suspect product, suspect product start date, action taken with suspect product, no hospitalization required, events onset date, events outcome and reaction data (additional events of device misuse, burn blister, scab, blister rupture and wound secretion).This case assessed as a reportable, initial 10-day (b)(4)/30-day fda report.Company clinical evaluation comment based on the information provided, the events burns second degree, blister rupture, wound secretion, and device misuse as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The events pruritus and scab assessed as associated with the device use.This case meets initial 10-day (b)(4) and 30-day fda reportability.Case comment: based on the information provided, the events burns second degree, blister rupture, wound secretion, and device misuse as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The events pruritus and scab assessed as associated with the device use.This case meets initial 10-day (b)(4) and 30-day fda reportability.

Manufacturer Narrative

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, 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] , used the heatwrap overnight while sleeping/she read the usage instructions prior to heatwrap usage [intentional device misuse], large burn blister and surrounding red area itching/ended up with large blister and surrounding red area itching [burns second degree], blister broke [blister rupture], blister broke, lots of fluid/open wound [wound secretion], used heatwrap for leg cramps/she read the usage instructions prior to heatwrap usage [intentional device use issue], scab [scab], , narrative: this is a spontaneous report from a pfizer sponsored program pfizer.Com - general company information.A contactable consumer reported a 78-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip) from an unspecified date in (b)(6) 2015 for leg cramps.The patient's medical history was not reported.Concomitant medications were reported as none.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date in 2009 for an unspecified indication with no adverse effect.On an unspecified date in (b)(6) 2015, the patient reported she used the heatwrap overnight while sleeping for approximately 4 hours over her pajamas on her left calf.She stated she awoke and attempted to scratch her calf and felt a large blister.The patient got a mirror to look and noted a large burn blister about 1 inch in size and a very sore area around the burn blister about 2x2 inches in size, very red and itching.She mentioned the pain was pretty deep into her calf.After 4 days, the patient reported the blister broke, lots of fluid and she used band aid to keep clean, still sore and itching.After blister broke left a pretty deep hole and no scab.Three weeks later still no scab but still pain and itching.The patient was getting worried about the open wound on her leg and she kept it covered with 2 band aids and neosporin, still didn't heal, so she decided neosporin was stopping the forming of scab, so wiped it clean and just left band aids.10 days later it started to heal, scabbed over (but still itching and red around scab) but smaller area.Last scab fill of 1st week of oct, still some redness little to none itching." the patient assessed her skin tone as medium.She denied having sensitive skin or any skin abnormal skin conditions.The patient previously used other heat products for pain relief years ago without any adverse effect.She read the usage instructions prior to heatwrap usage.The patient mentioned action taken with the product was continued.Therapeutic measures taken included neosporin and band aids.No hospitalization was required as a result of the events.Clinical outcome of the events "used heatwrap for leg cramps/she read the usage instructions prior to heatwrap usage" and "used the heatwrap overnight while sleeping/she read the usage instructions prior to heatwrap usage" was unknown, of the other events was resolving.According to the product quality complaint group: 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, 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 (19oct2015): new information received from a contactable consumer includes: patient details, updated suspect product, suspect product start date, action taken with suspect product, no hospitalization required, events onset date, events outcome and reaction data (additional events of device misuse, burn blister, scab, blister rupture and wound secretion).This case assessed as a reportable, initial 10-day eu/30-day fda report.Follow-up (15jun2020): new information received from the product quality complaint group included investigational results.Follow-up attempts are completed.No further information is expected.

• 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: 5184653
• MDR Text Key: 29801877
• Report Number: 1066015-2015-00140
• 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: 09/08/2015

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
• Initial Date Manufacturer Received: 10/19/2015
• Initial Date FDA Received: 10/28/2015
• Supplement Dates Manufacturer Received: 10/19/2015
• Supplement Dates FDA Received: 06/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR