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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS 25 DAY TUBE SET (3); ARTHROSCOPE

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SMITH & NEPHEW, INC. DYONICS 25 DAY TUBE SET (3); ARTHROSCOPE Back to Search Results
Model Number 7211007
Device Problems Leak/Splash (1354); Pressure Problem (3012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/26/2018
Event Type  malfunction  
Manufacturer Narrative
There was no hospitalization required.No outcomes attributed to this event.
 
Manufacturer Narrative
Foreign zip code: (b)(6).
 
Event Description
It was reported that the device had some issues of overpressure, causing leaking that squirted up to the ceiling.There was no delay or patient injury reported.
 
Manufacturer Narrative
The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.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
DYONICS 25 DAY TUBE SET (3)
Type of Device
ARTHROSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave
oklahoma city OK 73107 6512
Manufacturer (Section G)
SMITH & NEPHEW, INC.
76 s. me7ridian ave.
oklahoma city OK 73107 6512
Manufacturer Contact
jim gonzales
7000 west william cannon drive
austin, TX 78735
MDR Report Key7667200
MDR Text Key113586570
Report Number1643264-2018-00519
Device Sequence Number1
Product Code HRX
UDI-Device Identifier03596010543608
UDI-Public(01)03596010543608(17)200930(10)50688195
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K051326
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 08/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2020
Device Model Number7211007
Device Catalogue Number7211007
Device Lot Number50688195
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/04/2018
Initial Date FDA Received07/06/2018
Supplement Dates Manufacturer Received07/04/2018
08/03/2018
Supplement Dates FDA Received07/10/2018
08/08/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/29/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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