MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8303, L ALEXIS WND PROT/RET 5/BX RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL

Model Number C8303

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/09/2021

Event Type  malfunction  

Manufacturer Narrative

The event unit returned to applied medical for evaluation. A follow-up report will be provided upon completion of the investigation.

Event Description

Name of procedure being performed na (incoming inspection) detailed description of event: [name] incoming inspection po#(b)(4). We would like to inform you that some of the products didn't pass our receiving inspection. There is a item require cer in this report. Particulate: hair, bug - c8303 lot# 1424309 (1 ea). Additional information received via email 01nov2021 from [name] regulatory affairs and quality assurance: it was reported that there was only one bug found. No report of hair in packaging. Patient status: na (no patient involvement). Type of intervention: na (incoming inspection).

• Brand Name: C8303, L ALEXIS WND PROT/RET 5/BX
• 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: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 12865965
• MDR Text Key: 285616929
• Report Number: 2027111-2021-00738
• Device Sequence Number: 1
• Product Code: KGW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/11/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: C8303
• Device Catalogue Number: 101355901
• Device Lot Number: 1424309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial