MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; THERMOMETER,DIGITAL,ORAL,F/C,30 SEC,BULK

Catalog Number	MDS9950B
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported by the customer contact that "baby's temp was measured lower than the normally accepted range for an infant.Temperature was measured several times.Thie delayed discharge in this instance.Caused the infant to remain in the nicu 2 more days".It was reported that "the baby is home after using a different thermometer and finding the that medline thermometer was reading low".A sample was requested to be returned for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
"the readings are consistently reading low by as much as 1*f".

• Common Device Name: THERMOMETER,DIGITAL,ORAL,F/C,30 SEC,BULK
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18300875
• Report Number: 1417592-2023-00494
• Device Sequence Number: 11557604
• Product Code: FLL
• UDI-Device Identifier: 10888277115637
• UDI-Public: 10888277115637
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/11/2023

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 Catalogue Number: MDS9950B
• Device Lot Number: L230130002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown