MAUDE Adverse Event Report: MEDICAL DEVICES EVALUMED; LARYNGOSCOPE

Model Number 3-01B4-011

Device Problem Product Quality Problem (1506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/15/2019

Event Type  malfunction  

Manufacturer Narrative

The suspect blades were not returned nor were pictures supplied to provide clarification of the customer's poor fitting claim.Eight (8) blades from one of the lot (rj) were tested on two (2) different reusable handles.All eight (8) blades properly installed and functioned on both handles.Without the suspect blades being returned for evaluation the customer complaint cannot be confirmed for poor fitting blades.

Event Description

The customer alleges that "poor fitting blades." no other details were provided and no patient injury/harm reported.

• Brand Name: EVALUMED
• Type of Device: LARYNGOSCOPE
• Manufacturer (Section D): MEDICAL DEVICES; wazirabad road, ugoki.; sialkot punjab,
• MDR Report Key: 8705180
• MDR Text Key: 148552073
• Report Number: 1314417-2019-00037
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3-01B4-011
• Device Lot Number: MK
• Type of Device Usage: N
• Patient Sequence Number: 1