MAUDE Adverse Event Report: SINGLE TOOTH TENACULUM; FORCEPS

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/24/2019

Event Type  Injury  

Event Description

Medical instrument broke while in surgery in my abdomen.Fragment passed.Fda safety report id# (b)(4).

• Brand Name: SINGLE TOOTH TENACULUM
• Type of Device: FORCEPS
• MDR Report Key: 8874382
• MDR Text Key: 153944113
• Report Number: MW5088896
• Device Sequence Number: 1
• Product Code: HTD
• 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: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/07/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Weight: 89