MAUDE Adverse Event Report: MEDLINE CARBON STEEL BLADE, #15 SURGICAL MESH

Catalog Number MDS15015LN

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 08/18/2016

Event Type  malfunction  

Event Description

Number 15 surgical blade tip broke off in pt during surgery.

• Brand Name: CARBON STEEL BLADE, #15
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): MEDLINE; mundelein IL 60060
• MDR Report Key: 5952300
• MDR Text Key: 54937118
• Report Number: MW5064762
• Device Sequence Number: 1
• Product Code: FTL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 09/13/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: MDS15015LN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage