MAUDE Adverse Event Report: AIRCRAFT MEDICAL LIMITED

Model Number X3-002-000

Device Problems Material Integrity Problem (2978); Appropriate Term/Code Not Available (3191)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

Title wang¿s forceps-assisted percutaneous insertion and fixation of peritoneal dialysis catheter source turk j anaesthesiol reanim, volume 45, 2017 (361-366) date of publication: 28 july 2017.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed, the unit was used during intubation with or without cricoid pressure.The device group was used on 40 patient.It was reported that, a heart rate was increased after insertion of the tracheal tube and there was a mucosal damage occurred in 2 of the 40 patients.There was a mouth damage found in 2 of the 40 patients and tooth damage occurred in 1 patient.

• Manufacturer (Section D): AIRCRAFT MEDICAL LIMITED; 7 cross way; dalgety bay,fi KY11 9JE; GB KY11 9JE
• Manufacturer (Section G): AIRCRAFT MEDICAL LIMITED; 7 cross way; dalgety bay,fi KY11 9JE; GB KY11 9JE
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 9132625
• MDR Text Key: 165591534
• Report Number: 3010244187-2019-00010
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: X3-002-000
• Device Catalogue Number: X3-002-000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/04/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR