MAUDE Adverse Event Report: SWANN-MORTON LTD SINGLE USE SCALPEL BLADE

Model Number 0205

Device Problem Mechanical Problem (1384)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/04/2018

Event Type  malfunction  

Event Description

Description given by the healthcare facility: "the 15 blade broke off in a patient. This was from the extremity pack. " no further information was given. We have contacted the customer to provide more information if available.

• Brand Name: SINGLE USE SCALPEL BLADE
• Type of Device: SINGLE USE SCALPEL BLADE
• Manufacturer (Section D): SWANN-MORTON LTD; penn works owlerton green; sheffield, S6 2B J; UK S6 2BJ
• Manufacturer (Section G): SWANN-MORTON LTD; penn works owlerton green; sheffield, S6 2B J; UK S6 2BJ
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7209625412
• MDR Report Key: 7541917
• MDR Text Key: 109628757
• Report Number: 9611194-2018-00001
• 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

• Type of Report: Initial,Followup
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 0205
• Device Catalogue Number: 0205
• Device Lot Number: 4771710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 04/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 05/24/2018 Patient Sequence Number: 1