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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS TOUCH 300ML CANISTER; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
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SMITH & NEPHEW MEDICAL LTD. RENASYS TOUCH 300ML CANISTER; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP Back to Search Results
Catalog Number 66801273
Device Problem Partial Blockage (1065)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/06/2020
Event Type  malfunction  
Event Description
It was reported that renasys touch pump alarm keep showing blockage on and off.There is no signs of blood clots and tubing was not kinked and canister is empty.Renays tubing and canister was changed to another batch and issue is being resolved.
 
Manufacturer Narrative
Additional information was received that identified that this event should be re-evaluated for mdr reporting.The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.
 
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Brand Name
RENASYS TOUCH 300ML CANISTER
Type of Device
NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
Manufacturer (Section D)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull HU3 2 BN
UK  HU3 2BN
MDR Report Key10471361
MDR Text Key204919635
Report Number8043484-2020-02687
Device Sequence Number1
Product Code OMP
UDI-Device Identifier04582111155108
UDI-Public4582111155108
Combination Product (y/n)N
PMA/PMN Number
K153209
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number66801273
Device Lot Number38824588
Date Manufacturer Received07/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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