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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS 19 FR ROUND DRAIN A KIT MESH, SURGICAL, POLYMERIC

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SMITH & NEPHEW MEDICAL LTD. RENASYS 19 FR ROUND DRAIN A KIT MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number 66801254
Device Problem Protective Measures Problem (3015)
Patient Problem Injury (2348)
Event Date 06/04/2020
Event Type  Injury  
Event Description
It was reported that during treatment a blockage alarm for drainage supplies was detected both in terms of touch and go, the alarm is triggered due to the t-piece, which apparently does not suck in enough air for ventilation. Important: problems do not arise with the whole drainage kit but with the drainage kit. Sales representative was present at the moment of the event and confirm that they glued a blind soft port and then the therapy ran without blockage. No harm or injury reported.
 
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Brand NameRENASYS 19 FR ROUND DRAIN A KIT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull east riding of yorkshire HU3 2 BN
UK HU3 2BN
Manufacturer (Section G)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull east riding of yorkshire HU3 2 BN
UK HU3 2BN
Manufacturer Contact
sarah freestone
101 hessle road
hull HU3 2-BN
UK   HU3 2BN
0447940038
MDR Report Key10205253
MDR Text Key196765455
Report Number8043484-2020-01103
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K112784
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number66801254
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/08/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/29/2020 Patient Sequence Number: 1
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