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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE (SILICONE CUFF) CPV SIZE 4
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TELEFLEX MEDICAL LMA UNIQUE (SILICONE CUFF) CPV SIZE 4 Back to Search Results
Catalog Number 105200-000040
Device Problem Material Integrity Problem (2978)
Patient Problem No Patient Involvement (2645)
Event Date 07/30/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint is reported as: "the valve broke on the product and would not inflate or deflate back down." no patient involvement reported.
 
Manufacturer Narrative
(b)(4).The sample was returned for evaluation.A visual exam was performed and no damage was observed from the outer profile of the device.Functional testing was also performed and the device could be inflated and deflated with a syringe.No issues were found.A device history record review was performed and no relevant findings were identified.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned device.
 
Event Description
The complaint is reported as: "the valve broke on the product and would not inflate or deflate back down." no patient involvement reported.
 
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Brand Name
LMA UNIQUE (SILICONE CUFF) CPV SIZE 4
Type of Device
LMA UNIQUE
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
MDR Report Key8912660
MDR Text Key155057822
Report Number3011137372-2019-00256
Device Sequence Number1
Product Code CAE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date10/28/2021
Device Catalogue Number105200-000040
Device Lot NumberNRAH2B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/11/2019
Date Manufacturer Received10/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NOT REPORTED; NOT REPORTED
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