MAUDE Adverse Event Report: RESPIRE MEDICAL RESPIRE PINK SERIES - HERBST; DEVICE, ANTI SNORING

Device Problem Detachment Of Device Component (1104)

Patient Problem Discomfort (2330)

Event Date 01/12/2017

Event Type  malfunction  

Manufacturer Narrative

This product has been a part of fda 483 and has been subsequently recalled with the knowledge of the fda.(b)(4) was opened to address this incident.Further investigation is being carried out.

Event Description

A customer reported to respire medical that the posterior eyelet of the arm has separated from the hinge of the body.

• Brand Name: RESPIRE PINK SERIES - HERBST
• Type of Device: DEVICE, ANTI SNORING
• Manufacturer (Section D): RESPIRE MEDICAL; 18 bridge street, suite 4j; brooklyn NY 11201
• Manufacturer (Section G): RESPIRE MEDICAL; 18 bridge street, suite 4j; brooklyn NY 11201
• Manufacturer Contact: madubuike okafor ; 18 bridge street, suite 4j; brooklyn, NY 11201 ; 7183609209
• MDR Report Key: 7606318
• MDR Text Key: 111434534
• Report Number: 3008937561-2018-00004
• Device Sequence Number: 1
• Product Code: LRK
• Combination Product (y/n): N
• PMA/PMN Number: K131138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/08/2018

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/12/2017
• Initial Date FDA Received: 06/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2015
• 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