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

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.

• Brand Name: UNKNOWN
• Type of Device: RING (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 Key: 11520294
• MDR Text Key: 253590675
• Report Number: 2027111-2021-00397
• Device Sequence Number: 1
• Product Code: KGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• 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 Received: 03/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• 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 Received: 03/08/2021
• 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