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

Device Problem Use of Device Problem (1670)

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033); Swelling (2091)

Event Type  Injury  

Event Description

Allergic rash, blister [blister], allergic rash, blister [dermatitis allergic], at first use the heat wrap was applied directly on the skin [wrong technique in device usage process].Narrative: this is a spontaneous report from a contactable pharmacist.A (b)(6) female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number unknown, from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.At first use the heat wrap was applied directly on the skin, the second one over clothes, and both times she developed allergic rash and blisters on the skin.The action taken in response to the event for thermacare heatwrap and event outcome was unknown.Additional information has been requested and will be provided as it becomes available.

Manufacturer Narrative

Site sample status was not received.Summary of investigations: root cause was non-assignable.This investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.There was limited device specific information provided, no batch number 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.

Event Description

Event verbatim [preferred term].At first use the heat wrap was applied directly on the skin [device use error], blisters on the skin [blister], skin allergy [dermatitis allergic].Narrative: this is a spontaneous report from a contactable pharmacist.A 61-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number unknown, from an unspecified date at unknown frequency for an unspecified indication.The patient's medical history and concomitant medications were not reported.After using the heat wrap, the patient got a skin allergy.At the first time of use, the patch was applied directly on the skin and the second use the patient applied it over clothes.Both times she got blisters on the skin.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events was unknown.According to the product quality complaint group: severity of harm was s3.Site sample status was not received.Summary of investigations: root cause was non-assignable.This investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.There was limited device specific information provided, no batch number 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.Follow-up (12jun2020): follow-up attempts completed.No further information expected.Follow-up (05jul2020): this is a follow-up report from the product quality complaint group includes investigational results and event updated from allergic rash to skin allergy.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: 10129338
• MDR Text Key: 194460610
• Report Number: 1066015-2020-00126
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 05/28/2020

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: 06/08/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR