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

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

Patient Problem No Code Available (3191)

Event Type  malfunction  

Event Description

I used the wrap on my neck and somehow i ate some of it [accidental device ingestion] ,.Case narrative:this is a spontaneous report from a non-contactable consumer (patient).A (b)(6) year-old patient of an unspecified gender started to use thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number and expiration date not provided) from an unspecified date for an unspecified indication.Relevant medical history and the relevant concomitant medications were unknown at the time of this report.Patient reported on unknown date to have used the wrap on neck and somehow patient ate some of it.Patient was asking what to do.Action taken with the thermacare therapy in response to the event and the outcome of the event were unknown at the time of this report.No follow-up attempts are possible.No further information is expected., comment: based on the available information, the report of "used the wrap on neck and somehow patient ate some of it" was considered serious as it may necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure or function.A causal relationship between the device and the reported event cannot be ruled out.

Event Description

Event verbatim [preferred term].I used the wrap on my neck and somehow i ate some of it [accidental device ingestion].Narrative: this is a spontaneous report from a non-contactable consumer (patient).An 18-year-old patient of an unspecified gender started to use thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number and expiration date not provided) from an unspecified date for an unspecified indication.Relevant medical history and the relevant concomitant medications were unknown at the time of this report.Patient reported on unknown date to have used the wrap on neck and somehow patient ate some of it.Patient was asking what to do.Action taken with the thermacare therapy in response to the event and the outcome of the event were unknown at the time of this report.According to product complaint group: severity of harm is s3.Site had not received sample.This investigation was conducted for an unknown lot number neck/shoulder/wrist (nsw) 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 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/serious/unknown.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 assessment and rationale: a lot trend was not performed.The lot number is unknown.No follow-up attempts are possible.No further information is expected.Follow up (07may2020): new information received from product complaint group includes investigation results.No follow-up attempts are possible.No further information is expected.

Manufacturer Narrative

This investigation was conducted for an unknown lot number neck/shoulder/wrist (nsw) 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 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/serious/unknown.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 assessment and rationale: a lot trend was not performed.The lot number is unknown.

• 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: 9898842
• MDR Text Key: 189094234
• Report Number: 1066015-2020-00089
• 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: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/30/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 18 YR