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: COVIDIEN LP - SUPERDIMENSION INC CROSSCOUNTY; BRONCHOSCOPE (FLEXIBLE OR RIGID)
  • 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
 

COVIDIEN LP - SUPERDIMENSION INC CROSSCOUNTY; BRONCHOSCOPE (FLEXIBLE OR RIGID) Back to Search Results
Model Number SDATSW01
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Hemoptysis (1887)
Date of Event 04/22/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, post-operatively, the patient complained of blood stained sputum while admitted for post ablation syndrome.The patient was treated with oral transamin.The patient was hospitalized from (b)(6) 2020 to (b)(6) 2020.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CROSSCOUNTY
Common Device Name
BRONCHOSCOPE (FLEXIBLE OR RIGID)
Manufacturer (Section D)
COVIDIEN LP - SUPERDIMENSION INC
161 cheshire lane, suite 100
plymouth MN 55441
MDR Report Key10413253
Report Number3004962788-2020-00047
Device Sequence Number2670156
Product Code EOQ
UDI-Device Identifier10884521539723
UDI-Public10884521539723
Combination Product (Y/N)N
Initial Reporter CountryHK
PMA/510(K) Number
K142934
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/17/2020
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 Health Professional
Device Expiration Date05/22/2020
Device Model NumberSDATSW01
Device Catalogue NumberSDATSW01
Device Lot Number510099
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/13/2020
Initial Report FDA Received Date08/17/2020
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 Hospitalization; Other;
Patient Age52 YR
-
-