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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LENS IPAD SET; MEDICAL DEVICE DATA SYSTEM
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SMITH & NEPHEW, INC. LENS IPAD SET; MEDICAL DEVICE DATA SYSTEM Back to Search Results
Catalog Number 72300099LRC
Device Problems Communication or Transmission Problem (2896); Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/17/2018
Event Type  malfunction  
Event Description
It was reported that there was a communication and connecting issue.There was a surgical delay greater than 30 minutes.
 
Manufacturer Narrative
This complaint (b)(4) is a duplicate of the complaint (b)(4), that was reported under the report number 1643264-2018-00874.
 
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Brand Name
LENS IPAD SET
Type of Device
MEDICAL DEVICE DATA SYSTEM
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
Manufacturer (Section G)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
Manufacturer Contact
jim gonzales
7000 west william cannon drive
austin, TX 78735
5123485706
MDR Report Key8073807
MDR Text Key127370335
Report Number3003604053-2018-00175
Device Sequence Number1
Product Code OUG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number72300099LRC
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/24/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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