MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE NECK, SHOULDER & WRIST; DISPOSABLE PACK, HOT

Lot Number T65612

Device Problem Material Integrity Problem (2978)

Patient Problems Swelling (2091); Discharge (2225); Partial thickness (Second Degree) Burn (2694)

Event Date 02/01/2019

Event Type  Injury  

Event Description

Event verbatim (preferred term) oozing burn blisters (burns second degree).Case narrative: this is a spontaneous report from a contactable pharmacist.A female patient, between 50 and 60 years old, started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), via an unspecified route of administration from (b)(6) 2019, single for neck pain.Lot# t65612, and expiration date: oct2020 were provided.The patient medical history was not reported and concomitant medications were unknown.The patient experienced oozing burn blisters on (b)(6) 2019.The burn blisters were considered medically significant because they required medical or surgical intervention.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the event 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 of "burn blisters" as described is considered serious bodily injury 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 of "burn blisters" as described is considered serious bodily injury 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

Investigation summary: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reported receiving a burn.The cause of the burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.This is a potential device malfunction s3 skin burn- per rpt- 74091 bridging pfizer hal severity numbers applied in the thermacare heat wrap rmp, effective (b)(6) 2018, version 1.0.A site investigation was conducted on production records, a return sample was not received.A device malfunction was not identified during records review.

Event Description

Event verbatim [preferred term] oozing burn blisters [burns second degree] ,.Case narrative:this is a spontaneous report from a contactable pharmacist.A female patient, between 50 and 60 years old, started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), via an unspecified route of administration from 31jan2019, single for neck pain.Lot# t65612, and expiration date: oct2020 were provided.The patient medical history was not reported and concomitant medications were unknown.The patient experienced oozing burn blisters on 01feb2019.The burn blisters were considered medically significant because they required medical or surgical intervention.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the event was unknown.According to product quality complaint group: investigation summary: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reported receiving a burn.The cause of the burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.This is a potential device malfunction s3 skin burn- per rpt- 74091 bridging pfizer hal severity numbers applied in the thermacare heat wrap rmp, effective 28sep2018, version 1.0.A site investigation was conducted on production records, a return sample was not received.A device malfunction was not identified during records review.Follow-up (01apr2019): follow-up attempts completed.No further information expected.Follow-up (05jun2019): new information received from the product quality complaint group included: investigation results.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the information provided, the event of "burn blisters" as described is considered serious bodily injury 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.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the event of "burn blisters" as described is considered serious bodily injury 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.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.

• Brand Name: THERMACARE NECK, SHOULDER & WRIST
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 8325214
• MDR Text Key: 135697215
• Report Number: 1066015-2019-00029
• 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: 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2020
• Device Lot Number: T65612
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 55 YR