MAUDE Adverse Event Report: SURGICAL SAW; SAW, ELECTRICALLY POWERED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Purulent Discharge (1812); Scarring (2061); Tissue Breakdown (2681); Device Embedded In Tissue or Plaque (3165)

Event Date 07/23/2018

Event Type  Injury  

Event Description

In 6-8 weeks post surgery, open pruritic lesions in skin began.A month or two later nano-sized square bits of light reflective metal began surfacing in lesions and in surrounding skin of left forearm; continuing to be present in minor skin breaks (such as skinned knee, minor burn on forearm, abscesses appearing on forearms regularly) requiring medical treatment, but no one knows what this is.I cannot find medical diagnostics or treatment for symptoms until i am treating (b)(6).This metal becomes tangled in skin tissue and actually creates large lumps.It feels like large splinters and is causing horrible scars.Fda safety report id# (b)(4).

• Brand Name: SURGICAL SAW
• Type of Device: SAW, ELECTRICALLY POWERED
• MDR Report Key: 10043124
• MDR Text Key: 190664436
• Report Number: MW5094441
• Device Sequence Number: 1
• Product Code: DWI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 64