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

Catalog Number 50057536

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2015

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.Usage beyond the stated use life of one year and distorting the clamp during usage causing breakage of the clamp.The directions for use warns, "caution: modification, over-extending, bending, or use exceeding one year may cause breakage." the user used the clamp beyond the stated use life and in a manner that is contraindicated.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." dfu indicate "attach a floss safety line to bow or clamp jaws.And tie safety line to the frame.".

Event Description

Dds emailed concern describing incident involving a (b)(6) female.Rubber dam clamp broke while being removed from patient's mouth.When the clamp split in half, part was ejected out of the patients mouth and into her lap and the other half lodged in her oral-pharynx against her tonsils.Upon sitting the patient upright she was able to cough the fragment of the clamp out of her mouth.Both portions of the clamp were accounted for, sterilized, and sent in for evaluation.Luckily the patient was only scared, no other harm came to her.Upon speaking with the dental assistant, the clamp was only partially ligatured and the dds was using hu-friedy forceps.

• Brand Name: IVORY CLAMP
• 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: 5210705
• MDR Text Key: 31084470
• Report Number: 1821514-2015-00032
• Device Sequence Number: 1
• Product Code: EEF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 10/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 05/01/2000
• Device Catalogue Number: 50057536
• Device Lot Number: R5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/1995
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR