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

Device Problems Device Expiration Issue (1216); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Erythema (1840); Partial thickness (Second Degree) Burn (2694)

Event Date 01/12/2016

Event Type  Injury  

Event Description

Burn blister [burns second degree].Red marks from the circles from the wrap [erythema].Use an expired product [expired device used].Case description: this is a spontaneous report from a contactable consumer or other non hcp.A (b)(6) hispanic female patient started to use thermacare heatwrap (thermacare neck, shoulder & wrist) (expiration date: sep2015) from an unspecified date for neck pain.The patient's medical history and concomitant medications were not reported.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.On (b)(6) 2016, the patient reported she used the heatwrap and experienced a burn blister and red marks from the circles from the wrap.She mentioned she used an expired product.Action taken with the suspect product was unknown.Therapeutic measures taken included an unspecified burn ointment on an unspecified date.Clinical outcome of the events was reported as not resolved.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment based on the information provided, the event "burn blister" as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the event "burn blister" as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.

Manufacturer Narrative

This investigation was conducted for an unknown lot number neck/shoulder/wrist (nsw) 8 hour product.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 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.Site sample status was not received.A lot trend was not performed.The lot number is unknown.

Event Description

Event verbatim [preferred term].Burn blister [burns second degree], red marks from the circles from the wrap [erythema], use an expired product [expired device used].Narrative: this is a spontaneous report from a contactable consumer.A 38-year-old female patient started to use thermacare heatwrap (thermacare neck, shoulder & wrist) (expiration date: sep2015) from an unspecified date for neck pain.The patient's medical history and concomitant medications were not reported.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.On (b)(6) 2016, the patient reported she used the heatwrap and experienced a burn blister and red marks from the circles from the wrap.She mentioned she used an expired product.Action taken with the suspect product was unknown.Therapeutic measures taken included an unspecified burn ointment on an unspecified date.Clinical outcome of the events burn blister and red marks from the circles from the wrap was reported as not resolved.Clinical outcome of the remaining event was unknown.Additional information received from product quality complaint (pqc) group included investigation results.This investigation was conducted for an unknown lot number neck/shoulder/wrist (nsw) 8 hour product.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 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.Site sample status was not received.A lot trend was not performed.The lot number is unknown.Follow-up (10mar2016): follow-up attempts are completed.No further information is expected.Follow-up (02jun2020): new information received from product quality complaints (pqc) group included: product quality investigation results.No follow up attempts needed.No further information is expected.

• 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: 5390693
• MDR Text Key: 36906862
• Report Number: 1066015-2016-00014
• 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: 01/13/2016

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 Expiration Date: 09/01/2015
• Initial Date Manufacturer Received: 01/13/2016
• Initial Date FDA Received: 01/26/2016
• Supplement Dates Manufacturer Received: 01/13/2016
• Supplement Dates FDA Received: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR