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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACUFEX ACCESS ADV POS KIT; COMPONENT, TRACTION, NON-INVASIVE
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SMITH & NEPHEW, INC. ACUFEX ACCESS ADV POS KIT; COMPONENT, TRACTION, NON-INVASIVE Back to Search Results
Catalog Number 72205104
Device Problem Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/15/2019
Event Type  malfunction  
Event Description
It was reported that during the surgery the arm was wrapped and being held by the physicians assistant, it did not hold the arm.The physicians assistant had just connected patients wrapped arm to the access tower, and when the weights were applied to pull traction, the patient brace was pulled off the patient's forearm.A backup device was used to complete the surgery.No significant 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 provided image did not provide enough detail to determine a root cause.
 
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Brand Name
ACUFEX ACCESS ADV POS KIT
Type of Device
COMPONENT, TRACTION, NON-INVASIVE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
MDR Report Key8479022
MDR Text Key141015191
Report Number1643264-2019-00245
Device Sequence Number1
Product Code KQZ
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 05/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/26/2020
Device Catalogue Number72205104
Device Lot Number50766949
Was Device Available for Evaluation? No
Date Manufacturer Received05/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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