MAUDE Adverse Event Report: D R BURTON D R BURTON VPEP; PEP DEVICE

Device Problems Break (1069); Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/23/2017

Event Type  Injury  

Event Description

D r burton oscillatory vpep have multiple cracks and shards of plastic from patient dropping on floor.The d r burton oscillatory vpep devices consistently break and shatter.The concern is the patient will inhale or aspirate pieces of plastic in their lungs from the shattered mouthpiece.

• Brand Name: D R BURTON VPEP
• Type of Device: PEP DEVICE
• Manufacturer (Section D): D R BURTON; farmville NC 27828
• MDR Report Key: 6282839
• MDR Text Key: 66078368
• Report Number: MW5067507
• Device Sequence Number: 1
• Product Code: BWF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 91