Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION OCEAN SINGLE DRAIN
  • 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
 

ATRIUM MEDICAL CORPORATION OCEAN SINGLE DRAIN Back to Search Results
Model Number 2002-400
Health Effect - Clinical Code Pneumothorax (2012)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.Related mdr's: 1219977-2017-00096, 1219977-2017-00097, 1219977-2017-00098 and 1219977-2017-00099.
 
Event or Problem Description
Report received stated a doctor was having an issue with a patient regarding a collapsed lung when using an ocean drain.
 
Additional Manufacturer Narrative
The initial mdr 1219977-2017-00100 was originally submitted based on information provided by the customer.Per additional information received we are now aware that there was not a fifth device product complaint.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
OCEAN SINGLE DRAIN
Common Device Name
OCEAN SINGLE DRAIN
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
hudson NH 03051
MDR Report Key6660061
Report Number1219977-2017-00100
Device Sequence Number18884622
Product Code KDQ
UDI-Device Identifier00650862100211
UDI-Public00650862100211
Combination Product (Y/N)N
Initial Reporter CountryJO
PMA/510(K) Number
K043582
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 06/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Physician
Device Model Number2002-400
Device Catalogue Number2002-400
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 06/09/2017
Supplement Date Received by Manufacturer06/27/2017
Initial Report FDA Received Date06/22/2017
Supplement Report FDA Received Date07/14/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
-
-