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

Lot Number S23830

Device Problems Defective Device (2588); Temperature Problem (3022)

Patient Problems Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Manufacturer Narrative

The root cause category is non-assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports an adverse event - 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.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.

Event Description

Event verbatim [preferred term]: the burn was oval in size of an activated carbon field.Burn degree: 1-2 [burns second degree], older than 55 and has worn the wrap directly on the skin [device use error], the burn was oval in size of an activated carbon field.Burn degree: 1-2 [burns first degree].Case narrative: this is a spontaneous report from a contactable pharmacist.A (b)(6) year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number s23830, from an unspecified date at an unspecified frequency for back pain.The patient medical history and concomitant medications were not reported.The patient had none concomitant disease.The patient did not sleep on her wrap but was older than 55 and she had worn the wrap directly on her skin.Thermacare was used for few hours.The patient experienced burn.The burn was oval in size of an activated carbon field.Burn degree: 1-2.No treatment was required.No scars or long term damage are expected.The action taken in response to the event for thermacare heatwrap was temporarily withdrawn and she will still use the medical device taking into account the precautionary measures.The outcome of the event "the burn was oval in size of an activated carbon field.Burn degree: 1-2" was resolved on unknown date.A causality was not reported.According to product quality complaint group: the root cause category is non-assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports an adverse event - 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.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.Follow-up (07dec2018): new information received from product quality complaint group included: investigation results.Follow-up (21dec2018): new information received from a contactable pharmacist includes: age of patient, outcome of event, indication, action taken, additional description of event.The case was upgraded to serious and reportable.Follow-up attempts completed.No further information expected.Company clinical evaluation comment: based on the information provided, the events of "second degree burns" and "device use error" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event of first degree burns is assessed as non-serious.The events are 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.In the case narrative there is evidence of device use error which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the events of "second degree burns" and "device use error" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event of first degree burns is assessed as non-serious.The events are 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.In the case narrative, there is evidence of device use error which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time.

• 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
• Manufacturer Contact: stella pietrafesa ; 235 e42nd street; new york, NY 10017
• MDR Report Key: 8206593
• MDR Text Key: 131764456
• Report Number: 1066015-2018-00211
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/16/2018

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
• Device Lot Number: S23830
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR