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: SWANN-MORTON LTD SWANN MORTON; SCALPEL BLADE
  • 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
 

SWANN-MORTON LTD SWANN MORTON; SCALPEL BLADE Back to Search Results
Model Number 0201, 0205
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 01/21/2019
Event Type  malfunction  
Event Description
Description given by healthcare facility: "broken blades in several packs".Upon requesting further information, it was stated by the healthcare facility that the type of procedure being performed at the time of the breakage was "open procedures and that "cutting tissue" was being done at the time of breakage.It was stated that 283 blades of each shape (0201, 0205) was affected.We have questioned this as it seems unprobable that this amount of blades would have been used in one procedure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SWANN MORTON
Type of Device
SCALPEL BLADE
Manufacturer (Section D)
SWANN-MORTON LTD
penn works owlerton green
sheffield,
UK 
Manufacturer (Section G)
SWANN-MORTON LTD
penn works owlerton green
sheffield,
UK  
Manufacturer Contact
kevin walls
33 golden eagle lane
littleton, CO 80127
7209625412
MDR Report Key8280962
MDR Text Key134362246
Report Number9611194-2019-00003
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0201, 0205
Device Catalogue Number0201, 0205
Device Lot Number4821710, 4891710
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/21/2019
Initial Date FDA Received01/28/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-