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U.S. Department of Health and Human Services

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

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RESPIRE MEDICAL RESPIRE PINK SERIES - HERBST; DEVICE, ANTI SNORING Back to Search Results
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.
 
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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 Key7606318
MDR Text Key111434534
Report Number3008937561-2018-00004
Device Sequence Number1
Product Code LRK
Combination Product (y/n)N
PMA/PMN Number
K131138
Number of Events Reported1
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 Received06/15/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/05/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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