MAUDE Adverse Event Report: AIRWAY MANAGEMENT TAP PAP NASAL PILLOW MASK; CPAP MASK

Catalog Number PAP-NP1-001

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Tooth Fracture (2428)

Event Date 05/08/2014

Event Type  Other  

Event Description

We rec'd a correspondence indicating that a pt broke a tooth on the upper tray of our tap pap nasal pillow mask.The pt did not read the user instructions, and instead bit down on the upper tray prior to performing the fitting.Additionally, the pt has a problem with tooth health, as she has only one tooth remaining on the left side of her mouth, and has needed to have several teeth extracted within the last 12 months.After the tooth was broken, the pt performed the fitting of the upper tray.No medical intervention was taken.

• Brand Name: TAP PAP NASAL PILLOW MASK
• Type of Device: CPAP MASK
• Manufacturer (Section D): AIRWAY MANAGEMENT; 3418 midcourt #114; carrollton TX 75006
• Manufacturer Contact: dale siebenmorgen ; 3418 midcourt; #114; carrollton, TX 75006 ; 2143690978
• MDR Report Key: 3834850
• MDR Text Key: 4393802
• Report Number: 3003496134-2014-00001
• Device Sequence Number: 1
• Product Code: LRK
• Combination Product (y/n): N
• PMA/PMN Number: K122350
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: PAP-NP1-001
• Device Lot Number: NP1001-0DRH-13
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/13/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other