MAUDE Adverse Event Report: KERR ITALIA S.R.L. TEMPBOND NE; TEMPORARY DENTAL CEMENT

Catalog Number 60256

Device Problem Material Integrity Problem (2978)

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

The dentist treated the patients with dontisolon.The dentist indicated that no other information could be provided.The returned product was evaluated, yielding results within specifications.

Event Description

A doctor's office had alleged that three (3) patients experienced gingivitis after dental procedures in which temp bond ne was utilized.This is report one (1) of three (3).

• Brand Name: TEMPBOND NE
• Type of Device: TEMPORARY DENTAL CEMENT
• Manufacturer (Section D): KERR ITALIA S.R.L.; via passanti 332; scafati (sa), I-840 18; IT I-84018
• Manufacturer (Section G): KERR ITALIA S.R.L.; via passanti 332; scafati (sa), I-840 18; IT I-84018
• Manufacturer Contact: mark dzendzel ; 1717 w collins ave; orange, CA 92867 ; 7145167802
• MDR Report Key: 5264685
• MDR Text Key: 32626496
• Report Number: 8020994-2015-00002
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K003658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: 60256
• Device Lot Number: 5355539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2015
• 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
• Patient Outcome(s): Other; Required Intervention