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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS TOUCH NON CONNECT 4TH ED DEVICE; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
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SMITH & NEPHEW MEDICAL LTD. RENASYS TOUCH NON CONNECT 4TH ED DEVICE; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP Back to Search Results
Catalog Number 66802134
Device Problem Failure to Charge (1085)
Patient Problem No Information (3190)
Event Date 10/26/2020
Event Type  malfunction  
Event Description
It was reported that during treatment, the renasys touch device had a charging problem, which caused the patient to stop the therapy.It is unknown how the treatment was completed.An injury to the patient was reported, but further details are not known.
 
Manufacturer Narrative
H10.The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.B5 updated.
 
Event Description
It was reported that during treatment, the renasys touch device had a charging problem, which caused the patient to stop the therapy until a back-up device was delivered.Treatment was completed with the back-up device.
 
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Brand Name
RENASYS TOUCH NON CONNECT 4TH ED DEVICE
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 Key10859998
MDR Text Key216836229
Report Number8043484-2020-03932
Device Sequence Number1
Product Code OMP
Combination Product (y/n)N
PMA/PMN Number
K181204
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number66802134
Date Manufacturer Received02/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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