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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. RICHARD-ALLAN FREE NEEDLE NEEDLE, SUTURING, DISPOSABLE

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ASPEN SURGICAL PRODUCTS, INC. RICHARD-ALLAN FREE NEEDLE NEEDLE, SUTURING, DISPOSABLE Back to Search Results
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/18/2020
Event Type  Injury  
Event Description
During a quadriceps repair, sutures from swivelock anchors were used to re-imbricate the repair, and a suture needle broke. The suture needle was removed in its entirety, and an intraop xray was done confirmed no retained foreign objects. Fda safety report id # (b)(4).
 
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Brand NameRICHARD-ALLAN FREE NEEDLE
Type of DeviceNEEDLE, SUTURING, DISPOSABLE
Manufacturer (Section D)
ASPEN SURGICAL PRODUCTS, INC.
MDR Report Key10884747
MDR Text Key217966325
Report NumberMW5098023
Device Sequence Number1
Product Code GAB
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 11/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 11/20/2020 Patient Sequence Number: 1
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