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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8301, S ALEXIS WND PROT/RET 5/BX RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL

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APPLIED MEDICAL RESOURCES C8301, S ALEXIS WND PROT/RET 5/BX RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL Back to Search Results
Model Number C8301
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/19/2021
Event Type  malfunction  
Manufacturer Narrative
Event unit will not return to applied medical for evaluation. A follow-up report will be provided upon completion of the investigation.
 
Event Description
Name of procedure performed: tha. Hospital: [name], "when alexis was used on the left tha and [name ] removed alexis after tha treatment, the sleeve tear and the outer ring and inner ring were separated. After that, the inner ring was removed using a tether. Surgeon checked if there were any remaining pieces of sleeve in the wound, and then the wound was closed and the surgery was completed. " photos of the device have been provided. No product return. Additional information received via email on 21apr2021 from [name]: metal retractors, drills, and bone chisels were used through the device. The metal retractors was used for the exclusion of muscles and tissues. The drill was used for bone trimming and implant connection. The bone chisel was used for trimming bones. All pieces of the product was removed. The product was disposed of after the case as it was contaminated by blood. Patient status: no patient injury. Type of intervention: device was removed and patient was inspected for pieces of the product. Wound was then closed and surgery completed.
 
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Brand NameC8301, S ALEXIS WND PROT/RET 5/BX
Type of DeviceRING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL
Manufacturer (Section D)
APPLIED MEDICAL RESOURCES
22872 avenida empresa
rancho santa margarita CA 92688
Manufacturer Contact
wendy kobayashi
22872 avenida empresa
rancho santa margarita, CA 92688
9497138059
MDR Report Key11803246
MDR Text Key250354086
Report Number2027111-2021-00485
Device Sequence Number1
Product Code KGW
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberC8301
Device Catalogue Number100726601
Device Lot Number1392024
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/24/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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