MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L GENERAL PURPOSE TEMPERATURE PROBE; CLINICAL ELECTRONIC THERMOMETER

Model Number 81-020409

Device Problems Detachment of Device or Device Component (2907); Appropriate Term/Code Not Available (3191)

Patient Problems Gastritis (1874); Unspecified Gastrointestinal Problem (4491)

Event Date 04/08/2021

Event Type  Injury  

Manufacturer Narrative

Investigation finding: manufacturing plant inspected a total of (b)(4) units and all parts were found in compliance with the process specifications.Past complaint logs have been reviewed and confirmed of no similar issues have been reported.Root cause: no root cause determined.The sus involuntary report (mw5100669) stated the following, "patient was agitated in icu and may have bitten through the wire." lot information provided by the customer does not match any of the company's device history records (does not exist).The investigation is complete at this time.No further information is available at this time.We will provide follow up report if additional information becomes available.

Event Description

According to the customer a piece of the temperature probe was broken off and found inside the patient stomach.Patient potentially bit off the probe per sus voluntary event report (mw5100669).The sus voluntary event report stated the following: patient complains of abdomen distention and nausea.Abdomen without peritonitis or guarding.Obstruction series shows dilated small bowl, air in colon concern for ileus.But also shows a retained object in luq that is concerning for portion of dobhoff tube (feeding tube) vs esophageal temp probe that appears to be in the stomach.Chest x-ray showed intact dobhoff coursing through esophagus into stomach gi consulted for esophagogastroduodenoscopy (egd).Egd appeared to be a fractured dobhoff tube in the body of the stomach that extended into the antrum and into the duodenum.Some gastritis with hematin likely from the trauma from the presence of a foreign body in this regin.Pathology report of a 0.3 cm in diameter rubbery tan white rubber coated wire.Sounds like the esophageal probe.Patient was agitated in icu and may have bitten through the wire.

• Brand Name: GENERAL PURPOSE TEMPERATURE PROBE
• Type of Device: CLINICAL ELECTRONIC THERMOMETER
• Manufacturer (Section D): DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L; global park, p.o. box 180-3006; 602 parkway, la aurora; heredia 146 ; CS 146
• Manufacturer (Section G): DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L; global park, p.o. box 180-3006; 602 parkway, la aurora; heredia 146 ; CS 146
• Manufacturer Contact: krupa bhalodia ; 200 debusk lane; powell, TN 37849 ; 8653621013
• MDR Report Key: 11744372
• MDR Text Key: 247912127
• Report Number: 9613793-2021-00011
• Device Sequence Number: 1
• Product Code: FLL
• UDI-Device Identifier: 00749756046145
• UDI-Public: 00749756046145
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 81-020409
• Device Lot Number: 223800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2021
• 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
• Removal/Correction Number: MW5100669
• Patient Sequence Number: 1
• Patient Outcome(s): Other