MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAP; DISPOSABLE PACK, HOT

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Skin Irritation (2076); Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Event Description

They gave her a bad burn which turned into a blister in the whole area.Stated that she had stinging and the area burned [burns second degree] ,.Case narrative: this is a spontaneous report from a contactable consumer reporting for herself.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare heatwrap), via an unspecified route of administration from an unspecified date to an unspecified date at an unspecified dose for an unspecified indication.The patient medical history and concomitant medications were not reported.The consumer stated that she bought the wraps at (store name) and she had been using them and then all of a sudden, they gave her a bad burn which turned into a blister in the whole area.Stated that she had stinging and the area burned.Age of onset: 40 years ago (pending clarification).The consumer stated that pfizer has been calling her to get her to report this.Stated that the product had a recall.She has not called to report this to safety previously and that she has not received letters from pfizer; she has just received calls and pfizer has really been calling her.The action taken for the product and event outcome 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 second degree as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device., comment: based on the information provided, the event burns second degree as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.

Manufacturer Narrative

Summary of investigation: 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, 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.The sample had not been received by the site.

Event Description

Event verbatim [preferred term] they gave her a bad burn which turned into a blister in the whole area.Stated that she had stinging and the area burned [burns second degree].Narrative: this is a spontaneous report from a contactable consumer reporting for herself.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare heatwrap), via an unspecified route of administration from an unspecified date to an unspecified date at an unspecified dose for an unspecified indication.The patient medical history and concomitant medications were not reported.The consumer stated that she bought the wraps at (store name) and she had been using them and then all of a sudden, they gave her a bad burn which turned into a blister in the whole area.Stated that she had stinging and the area burned.Age of onset: 40 years ago.The consumer stated that pfizer has been calling her to get her to report this.Stated that the product had a recall.She has not called to report this to safety previously and that she has not received letters from pfizer; she has just received calls and pfizer has really been calling her.The action taken for the product and event outcome was unknown.According to product quality complaint group: summary of investigation: 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, 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.The sample had not been received by the site.Follow-up (22mar2019): follow-up attempts are completed.No further information is expected.Follow-up (22may2020): new information received from a product complaint group included: investigation results.

• Brand Name: THERMACARE HEATWRAP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 8016197
• MDR Text Key: 125430144
• Report Number: 1066015-2018-00122
• 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: 10/11/2018

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?: No
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/29/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention