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: SUNMED SUNMED; GREENLINE C/P MED HANDLE C
  • 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
 

SUNMED SUNMED; GREENLINE C/P MED HANDLE C Back to Search Results
Model Number 5-0236-09
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Laceration(s) (1946)
Event Date 01/25/2022
Event Type  Injury  
Manufacturer Narrative
The user was cut twice when opening the laryngoscope handle while checking batteries.This caused injury to caregiver and potentially could have delayed patient intubation.Based on the reported information and the event originating in the us, the criteria for reporting an adverse event have been met.
 
Event Description
Caregiver cut while unscrewing laryngoscope handle to check batteries.Caregiver was cut twice while unscrewing the laryngoscope to check the batteries.
 
Manufacturer Narrative
The user was cut twice when opening the laryngoscope handle while checking batteries.This caused injury to caregiver and potentially could have delayed patient intubation.Based on the reported information and the event originating in the us, the criteria for reporting an adverse event have been met.
 
Event Description
Caregiver cut while unscrewing laryngoscope handle to check batteries.Caregiver was cut twice while unscrewing the laryngoscope to check the batteries.
 
Event Description
Caregiver cut while unscrewing laryngoscope handle to check batteries.Caregiver was cut twice while unscrewing the laryngoscope to check the batteries.
 
Manufacturer Narrative
The user was cut twice when opening the laryngoscope handle while checking batteries.This caused injury to caregiver and potentially could have delayed patient intubation.Based on the reported information and the event originating in the us, the criteria for reporting an adverse event have been met.Complaint review completed.This is the only reported incident of this type for this product.Device was visually inspected and manually maneuvered as it would be during use and the alleged incident could not be replicated.Email response sent to the customer, as requested.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SUNMED
Type of Device
GREENLINE C/P MED HANDLE C
Manufacturer (Section D)
SUNMED
2710 northridge dr nw suite a
grand rapids MI 49544
Manufacturer (Section G)
SUNMED
2710 northridge dr nw suite a
grand rapids MI 49554
Manufacturer Contact
melissa brickley
2710 northridge dr nw suite a
grand rapids, MI 49544
6162598415
MDR Report Key13593953
MDR Text Key286121122
Report Number1314417-2022-00009
Device Sequence Number1
Product Code CCW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nurse Practitioner
Type of Report Initial,Followup
Report Date 02/24/2022
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? Yes
Device Operator Health Professional
Device Model Number5-0236-09
Device Lot NumberNF
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/24/2022
Initial Date Manufacturer Received 01/25/2022
Initial Date FDA Received02/24/2022
Supplement Dates Manufacturer Received01/25/2022
Supplement Dates FDA Received04/22/2022
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
-
-