MAUDE Adverse Event Report: ZYPPAH ZYPPAH

Model Number ZC-HYBRID ORAL APPLIANCE

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 01/29/2018

Event Type  No Answer Provided  

Event Description

I purchased the zyppah device in (b)(6) 2017, and started using regularly in (b)(6) 2017.(see product description below).While sleeping, the strap on my device broke from the posts holding it on one side one night in (b)(6) this year.If pieces had broken off, they could have caused a choking hazard.This potential hazard prompted my reporting the condition to your agency.Incident: no injury.Purchase date: (b)(6) 2017.

• Brand Name: ZYPPAH
• Type of Device: ZYPPAH
• Manufacturer (Section D): ZYPPAH
• MDR Report Key: 7344606
• MDR Text Key: 102847306
• Report Number: MW5075892
• Device Sequence Number: 1
• Product Code: LRK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ZC-HYBRID ORAL APPLIANCE
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR