MAUDE Adverse Event Report: HERAEUS KULZER, LLC IVORY RUBBER DAM FORCEPS; RUBBER DAM AND ACCESSORIES

Model Number IVORY RUBBER DAM FORCEPS

Device Problem Break (1069)

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

Event Date 02/18/2016

Event Type  malfunction  

Manufacturer Narrative

This device was used for many years beyond its five-year shelf life.Due to the aforementioned fact that this was customer misuse, no further action is deemed necessary at this time.The investigation is closed.Capa measures are not proposed or initiated.

Event Description

Package received by manufacturer containing letter and broken rubber dam forceps from dentist in (b)(6).Description is that forceps broke while in use.Forceps were found to be at least 25 years old, and expired by at least 20 years.

• Brand Name: IVORY RUBBER DAM FORCEPS
• Type of Device: RUBBER DAM AND ACCESSORIES
• Manufacturer (Section D): HERAEUS KULZER, LLC; 300 heraeus way; south bend IN 46614 2517
• Manufacturer (Section G): HERAEUS KULZER, LLC; 300 heraeus way; south bend IN 46614 2517
• Manufacturer Contact: rita rogers ; 300 heraeus way; south bend, IN 46614 ; 5742995409
• MDR Report Key: 5531956
• MDR Text Key: 41726051
• Report Number: 1821514-2016-00011
• Device Sequence Number: 1
• Product Code: EEF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 03/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Expiration Date: 01/01/1996
• Device Model Number: IVORY RUBBER DAM FORCEPS
• Device Catalogue Number: 50057220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1991
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1