MAUDE Adverse Event Report: ACCUTEC BLADES, INC. DERMABLADE; BUTTER BLADE SURGICAL

Model Number 72-0001

Device Problem Corroded (1131)

Patient Problem No Information (3190)

Event Date 11/13/2017

Event Type  malfunction  

Event Description

On (b)(6) 2017, an incident was internally filed within our hospital stating that the accutec blade inc.Dermablade product appeared to have rust on the blade.The sterile packaging was unopened nor was it past the expiration date of 09/2019.Dermablades, also known as the "butter blade", are designed and used specifically for dermaplaning (a procedure that improves skin texture and tone, stimulated collagen synthesis, softens and smooths skins, and minimizes pore size and appearance).The dermablade is a blend of stainless and carbon steel with a polymer coating so will stay sharp and glide effortlessly on the skin.Dermablades are individually packaged in sterilized material ((see "other considerations" for visual) that comes straight from the vendor.When the director of supply chain at (b)(6) medical center investigated this safety concern, he stated that there has been a lack of a response from the vendor.(b)(6) is unable to confirm whether these blades are defective or not.According to the director of supply chain at (b)(6) medical center, a coated blade can show some irregularity in the surface and still function.However, our organization needs the vendor to either confirm this is per their standard process or indicate that the rusty is a rep of a defect.At this time, supply chain is pursuing other possible sourcing paths for this supply.During a date analysis, it was discovered that there have been multiple pt safety alerts internally submitted regarding this same concern.In each case, the blade was reviewed prior to providing direct pt care.As such, there has been no reported pt harm.

• Brand Name: DERMABLADE
• Type of Device: BUTTER BLADE SURGICAL
• Manufacturer (Section D): ACCUTEC BLADES, INC.
• MDR Report Key: 7186539
• MDR Text Key: 97374777
• Report Number: MW5074551
• Device Sequence Number: 1
• Product Code: MDM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2019
• Device Model Number: 72-0001
• Device Lot Number: 1416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other