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U.S. Department of Health and Human Services

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

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APPLIED MEDICAL RESOURCES C8303, L ALEXIS WND PROT/RET 5/BX RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL Back to Search Results
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).
 
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Brand NameC8303, L 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
aaron fulcher
22872 avenida empresa
rancho santa margarita, CA 92688
9497135765
MDR Report Key12865965
MDR Text Key285616929
Report Number2027111-2021-00738
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 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 Received11/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberC8303
Device Catalogue Number101355901
Device Lot Number1424309
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/03/2021
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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