MAUDE Adverse Event Report: INTEGRA YORK, PA INC. MCIVOR FRAME ONLY; N/A

Catalog Number 450141

Device Problem Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to the manufacturer for analysis.There was one mcivor mouth gag, frame only returned used/processed with the complaint that a screw fell out of the frame.The product specification was reviewed and there is no screws missing from the returned instrument.No lot number was provided to perform device history record review.The complaint is unconfirmed/testing within specification.Device identifier: (b)(4).

Event Description

A sales representative reported in behalf of the customer that the screw of 450-141 mcivor frame fell off into the back of the patient¿s throat during an unspecified procedure.The surgeon was able to retrieve it.The date of the event was not known.There was no patient injury reported.Additional information has been requested.

• Brand Name: MCIVOR FRAME ONLY
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• Manufacturer (Section G): INTEGRA YORK, PA INC.; 589 davies drive; york PA 17402
• Manufacturer Contact: kimberly shelly ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 8549116
• MDR Text Key: 143572182
• Report Number: 2523190-2019-00057
• Device Sequence Number: 1
• Product Code: KBN
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 450141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2019
• Date Manufacturer Received: 04/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1