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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AZIYO BIOLOGICS, INC. CANGAROO ENVELOPE MESH, SURGICAL

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AZIYO BIOLOGICS, INC. CANGAROO ENVELOPE MESH, SURGICAL Back to Search Results
Model Number CMCV-009-MED
Device Problems Material Separation (1562); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/18/2020
Event Type  malfunction  
Event Description
This was an initial implant of a pacemaker: the scrub tech opened and prepared the equipment per manufacturer's instructions while in the room with the physician. After the preparation time, the device pouch was handed to the implanting physician. At this time the physician attempted to open the device for use. The sutures that are attached to the device in packaging began to dissolve/fall away from the pouch opening. Subsequently, the pouch separated on itself and was not deemed usable. Fda safety report id# (b)(4).
 
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Brand NameCANGAROO ENVELOPE
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
AZIYO BIOLOGICS, INC.
roswell GA 30076
MDR Report Key10648922
MDR Text Key210633799
Report NumberMW5097145
Device Sequence Number1
Product Code FTM
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 10/05/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/26/2021
Device Model NumberCMCV-009-MED
Device Lot NumberM19D1171050
Was Device Available for Evaluation? No
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? No
Type of Device Usage

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