MAUDE Adverse Event Report: KULZER, LLC IVORY RUBBER DAM CLAMP; CLAMP, RUBBER DAM

Model Number 12A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This complaint originated in (b)(6), and was reported to (b)(4).It was recorded by (b)(4) as safety-standard instead of safety-critical.(b)(4) was made aware (b)(4) 2017.There was no hazard for user, patient or third party.This malfunction is reportable as sec.803.50 states: if you are a manufacturer, you must report to us no later than 30 calendar days after the day that you receive or otherwise become aware of information, from any source, that reasonably suggests that a device that you market has malfunctioned and this device or a similar device that you market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.The malfunction will be reported to maintain compliance with 21 cfr 803 and out of an abundance of caution.

Event Description

This complaint came from a dealer in (b)(4).Clamp broken.

• Brand Name: IVORY RUBBER DAM CLAMP
• Type of Device: CLAMP, RUBBER DAM
• Manufacturer (Section D): KULZER, LLC; 4315 south lafayette blvd.; south bend 46614
• Manufacturer (Section G): KULZER, LLC; 4315 south lafayette blvd.; south bend IN 46614
• Manufacturer Contact: rita rogers ; 4315 south lafayette blvd.; south bend, IN 46614
• MDR Report Key: 6786283
• MDR Text Key: 82597902
• Report Number: 1821514-2017-00018
• Device Sequence Number: 1
• Product Code: EEF
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Expiration Date: 03/28/2021
• Device Model Number: 12A
• Device Catalogue Number: 50057348
• Device Lot Number: V6
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 9 MO
• Date Manufacturer Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2016
• 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