MAUDE Adverse Event Report: FLEXICARE MEDICAL DONGGUAN BRITEBLADE PRO SINGLE-USE FIBER OPTIC WIS-HIPPLE 2; LARYNGOSCOPE BLADE SINGLE USE

Catalog Number 040-00-1220U

Device Problem Insufficient Information (3190)

Patient Problem Abrasion (1689)

Event Date 08/05/2021

Event Type  malfunction  

Manufacturer Narrative

Attempted to establish full details of event including potential use of a laryngoscope blade which was the incorrect choice of length for procedure.No response from end user currently available.

Event Description

Abrasion to lip discovered after use.

• Brand Name: BRITEBLADE PRO SINGLE-USE FIBER OPTIC WIS-HIPPLE 2
• Type of Device: LARYNGOSCOPE BLADE SINGLE USE
• Manufacturer (Section D): FLEXICARE MEDICAL DONGGUAN; no.b-15 xicheng ind. zone 1; hengli town; dongguan city, guangdong 52346 0; CH 523460
• Manufacturer (Section G): FLEXICARE MEDICAL DONGGUAN; no. b-15 xicheng ind. zone 1; hengli town; dongguan city, guangdong 52346 0; CH 523460
• Manufacturer Contact: darryl ridge ; flexicare medical ltd; cynon valley business park; mountain ash, rct CF454-ER ; UK CF454ER
• MDR Report Key: 12446426
• MDR Text Key: 270519044
• Report Number: 3006061749-2021-00008
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 040-00-1220U
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1