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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES HR004, S/M ALEXIS ORTHO PROT 5/BX RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL

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APPLIED MEDICAL RESOURCES HR004, S/M ALEXIS ORTHO PROT 5/BX RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL Back to Search Results
Model Number HR004
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/17/2021
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 being performed "tha als approach with a 10 cm incision. " detailed description of event: complaint based on feedback id #: (b)(4). Submitted 23feb2021. Hospital: [name], (b)(6). "report from [name]. Using (b)(4) in first case in this hospital. Patient (female, thin) in supine position. " "the fixation of the inner ring was poor, and the orthopedic surgeon put it on and took it off several times during the operation, but the fixation of the vastus lateralis muscle was not stable throughout. The outer ring was wrapped inside. This is intraoperative view, metal retractors are used, but inner-ring is not stable. Additional information received via email on 26feb2021 from [name]. Cer form has been provided. "patient was old female. Anterior lateral approach and skin incision was 10cm. Alexis inner ring was placed below the vastus lateralis and outer ring was rolled down inward. Inner ting was not stable at the position and popped out. Surgeon commented inner ring did not fit in. Metal retractor was also used along with alexis. " product is not available for return. Patient status: no patient injury indicated. Type of intervention surgeon put it on and took it off several times during the operation. Metal retractors were also used alongside the device.
 
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Brand NameHR004, S/M ALEXIS ORTHO PROT 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 Key11478129
MDR Text Key250365247
Report Number2027111-2021-00386
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberHR004
Device Catalogue Number101428801
Device Lot Number1399866
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 Received02/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/30/2020
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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