MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS ESOPHAGEAL/RECTAL TEMPERTURE PROBE; TEMP PROBE

Model Number 21075A

Device Problems Device Operates Differently Than Expected (2913); Extrusion (2934)

Patient Problem Perforation (2001)

Event Type  Injury  

Event Description

The field organization reported that there was a serious injury (puncture) caused by the 21075a temperature probe.The injury required surgery to correct.

Manufacturer Narrative

Pr#: (b)(4).This complaint was created based on info received from the field organization in which a pt injury requiring surgery was reported.The info regarding this injury was received as part of an investigation for another unrelated issue.A follow up report will be submitted once the investigation is complete.

• Brand Name: ESOPHAGEAL/RECTAL TEMPERTURE PROBE
• Type of Device: TEMP PROBE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd.; andover MA 01810
• Manufacturer Contact: wendy chadbourne ; 3000 minuteman rd.; andover, MA 01810 ; 9786597804
• MDR Report Key: 4740188
• MDR Text Key: 5704070
• Report Number: 1218950-2015-02265
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K883793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 21075A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/28/2014
• Date Manufacturer Received: 09/25/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1