MAUDE Adverse Event Report: LABORIE MEDICAL TECHNOLOGIES CORP. LABORIE INJETAK ADJUSTABLE TIP NEEDLE; ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY

Lot Number D228088

Device Problem Nonstandard Device (1420)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/20/2023

Event Type  Injury  

Event Description

Recalled botox needle used during surgical case on (b)(6) 2023.Email sent to the charge rn 2/21/2023.No communication of recall prior to this email.As of 2/23/2023, patient had no sign of infection.

• Brand Name: LABORIE INJETAK ADJUSTABLE TIP NEEDLE
• Type of Device: ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): LABORIE MEDICAL TECHNOLOGIES CORP.
• MDR Report Key: 16461626
• MDR Text Key: 310595842
• Report Number: MW5115327
• Device Sequence Number: 1
• Product Code: FBK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: D228088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Race: White