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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Missing Information (4053)

Patient Problems Scar Tissue (2060); Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)

Event Date 08/01/2018

Event Type  Injury  

Event Description

Event verbatim [preferred term] close to second degree burns on her back/hurting and burning/burn blistered up [burns second degree] , scar/it had healed and he said he could still see the scars [scar],.Case narrative: this is a spontaneous report from a contactable consumer reporting for her mother.An (b)(6) female patient started to receive thermcare heatwrap (thermacare lower back & hip), expiration date: aug2020, from an unspecified date to an unspecified date at unknown frequency for lower back pain.Medical history were none.There were no concomitant medications.The reporter was calling about thermacare heatwraps lower back on behalf of her mom.Her mom had back problems and she bought a couple of boxes, she looked at the expiration date and the date in 2020.Her mom got close to second degree burns on her back in (b)(6) 2018.Her mom had a scar and everything.Her mom had called her to say that it was hurting and burning and she discovered the burn.This happened about 1.5-2 weeks ago.She put a bandage on her mom for burns and put medication on it, the burn blistered up.Then her mom told her she was going to use another one and she told her mom no, she did not believe they will use the boxes her mom had purchased and it was too late to take them back.Her mom had been using the thermacare heatwraps for lower back for about 7 years and had never had a problem before.She took her mom to see her back specialist after it had healed and he said he could still see the scars.Dr.(withheld) was her general practitioner but dr.(withheld), her pain specialist was the one who noticed the scar.She thought there was a reasonable possibility that "close to 2nd degree burns" is related to this device.The action taken in response to the event was permanently withdrawn in 2018.The outcome of the event was recovered with sequel.Her mom still had a full box and was unable to take them back, her mom thought thermacare should check into this.The sample of the product was available to be returned.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the events of burns second degree and scar as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events of burns second degree and scar as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term].Close to second degree burns on her back/hurting and burning/burn blistered up [burns second degree], scar/it had healed and he said he could still see the scars [scar].Narrative: this is a spontaneous report from a contactable consumer reporting for her mother.An 84-year-old female patient started to receive thermcare heatwrap (thermacare lower back & hip), expiration date: aug2020, from an unspecified date for about 7 years at unknown frequency for lower back pain.Medical history were none.There were no concomitant medications.The reporter was calling about thermacare heatwraps lower back on behalf of her mom.Her mom had back problems and she bought a couple of boxes, she looked at the expiration date and the date in 2020.Her mom got close to second degree burns on her back in (b)(6) 2018.Her mom had a scar and everything.Her mom had called her to say that it was hurting and burning and she discovered the burn.This happened about 1.5-2 weeks ago.She put a bandage on her mom for burns and put medication on it, the burn blistered up.Then her mom told her she was going to use another one and she told her mom no, she did not believe they will use the boxes her mom had purchased and it was too late to take them back.Her mom had been using the thermacare heatwraps for lower back for about 7 years and had never had a problem before.She took her mom to see her back specialist after it had healed and he said he could still see the scars.Dr.((b)(6)) was her general practitioner but dr.((b)(6)), her pain specialist was the one who noticed the scar.She thought there was a reasonable possibility that "close to 2nd degree burns" is related to this device.The reporter could not find a lot number on the box.The action taken in response to the event was permanently withdrawn in 2018.The outcome of the events was recovered with sequel.Her mom still had a full box and was unable to take them back, her mom thought thermacare should check into this.The sample of the product was available to be returned.According to product complaint group, this investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.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 lot# or expiry or manufacturing date is missing/illegible/incorrect.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 assessment and rationale: a lot trend was not performed as the lot number is unknown.Expedite trend assessment and rationale: this is not an expedite complaint.Site sample status was not received.Follow-up (28mar2019): follow-up attempts are completed.No further information is expected.Follow-up (05aug2020): new information received from a product complaint group included: investigation result.Follow-up attempts are completed.No further information is expected.

Manufacturer Narrative

This investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.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 lot# or expiry or manufacturing date is missing/illegible/incorrect.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 assessment and rationale: a lot trend was not performed as the lot number is unknown.Expedite trend assessment and rationale: this is not an expedite complaint.Site sample status was not received.

• 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: 7847883
• MDR Text Key: 119327186
• Report Number: 1066015-2018-00099
• 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: 08/29/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2020
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/05/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Weight: 86