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

Model Number 12A

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

Although we have not established that the device caused or contributed to the event, we're reporting it to be compliant with 21 cfr part 803 and out of an abundance of caution.Distorting the clamp during usage causing breakage of the clamp.Device breakage is addressed in the directions for use.The directions state, "do not place clamp in mouth until the rubber dam has been properly placed.Clamp could become a choking or safety hazard if dropped or broken in the mouth without proper use of the rubber dam at all times." the directions for use warns, "caution: modification, over-extending, bending, or use exceeding one year may cause breakage." the user used the clamp in a manner that is contraindicated by hyperextending the clamp.

Event Description

Broken clamp returned by (b)(6) dealer, no details.

• Brand Name: IVORY CALMP
• Type of Device: CLAMP, RUBBER DAM
• 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: 5875045
• MDR Text Key: 53038454
• Report Number: 1821514-2016-00023
• Device Sequence Number: 1
• Product Code: EEF
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 07/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/28/2020
• Device Model Number: 12A
• Device Catalogue Number: 50057348
• Device Lot Number: L5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1