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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SMITH+NEPHEW DEV; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
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SMITH & NEPHEW, INC. SMITH+NEPHEW DEV; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Injury (2348)
Event Date 04/03/2019
Event Type  Injury  
Event Description
It was reported that, after a left knee arthroscopy, the patient was found to have a burn in her left knee.It is unknown if further complications arose.
 
Manufacturer Narrative
H10 h3,h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.No product identification or supporting clinical information was provided.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
 
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Brand Name
SMITH+NEPHEW DEV
Type of Device
INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107
MDR Report Key10610176
MDR Text Key209338172
Report Number1643264-2020-01358
Device Sequence Number1
Product Code MDM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 10/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/06/2020
Initial Date FDA Received09/30/2020
Supplement Dates Manufacturer Received10/02/2020
Supplement Dates FDA Received10/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention;
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