MAUDE Adverse Event Report: SWANN MORTON, LTD DEROYAL N0. 15 CARBON STERILE BLADE; SCALPEL BLADE

Model Number 6205

Device Problem Mechanical Problem (1384)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

Explanation given by deroyal, blade broke in patient's foot during a procedure causing an additional procedure (fluoroscopy procedure) to locate it and remove it.Samples was discarded due to the blade being contaminated.

• Brand Name: DEROYAL N0. 15 CARBON STERILE BLADE
• Type of Device: SCALPEL BLADE
• Manufacturer (Section D): SWANN MORTON, LTD; owlerton green; sheffield, ; UK
• Manufacturer (Section G): SWANN MORTON, LTD; owlerton green; sheffield, ; UK
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7209625412
• MDR Report Key: 7094751
• MDR Text Key: 94097655
• Report Number: 9611194-2017-00008
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 6205
• Device Lot Number: 4221707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention