MAUDE Adverse Event Report: MIZUHO SUGITA; SUGITA SCALP HOOK

Catalog Number 07-954-00

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/28/2014

Event Type  Injury  

Event Description

Sugita scalp hook broke off in pt during use.Dates of use: (b)(6) 2014.

• Brand Name: SUGITA
• Type of Device: SUGITA SCALP HOOK
• Manufacturer (Section D): MIZUHO; union city CA 94587
• MDR Report Key: 3977525
• MDR Text Key: 17390490
• Report Number: MW5037558
• Device Sequence Number: 1
• Product Code: HBO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07-954-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/30/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR