• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES UNKNOWN RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

APPLIED MEDICAL RESOURCES UNKNOWN RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL Back to Search Results
Model Number UNKNOWN
Device Problem Device Handling Problem (3265)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Type  Injury  
Manufacturer Narrative
The event unit is not available for evaluation by applied medical. A follow-up report will be sent upon completion of the investigation.
 
Event Description
Name of procedure being performed: ni. Detailed description of event: "i am the patient safety officer for [name]. We have had an incident of an alexis o would retractor unintentionally being left inside of a patient postoperatively for many months. These are radiolucent devices and therefore cannot identified on post operative "rule out foreign body" radiographs. A radio-opaque marker should be included in the manufacturing of the device to make it radiographically visible. Response and proposed plan of action appreciated. I plan to submit my concerns to the fda as well. " patient status: product left in patient postoperatively for many months. Type of intervention: ni.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN
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 Key11520294
MDR Text Key253590675
Report Number2027111-2021-00397
Device Sequence Number1
Product Code KGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
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 Received03/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/18/2021 Patient Sequence Number: 1
-
-