MAUDE Adverse Event Report: DENTSPLY CAULK INTEGRITY TEMPGRIP; DENTAL CEMENT

Catalog Number 666450

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Swelling (2091); Reaction (2414)

Event Type  Injury  

Event Description

In this event, it was reported that an unknown number of patients experienced swollen lips after use of integrity temp grip cement.The event outcome is unknown as of this mdr evaluation.Additional information has been requested, but is not yet available.

Manufacturer Narrative

While it is unknown if the device used in this case caused or contributed to the patient's symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material.Therefore, this event meets the criteria for reportability per 21 cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

Manufacturer Narrative

Multiple unsuccessful attempts were made to obtain the pt outcome.Multiple unsuccessful attempts were made to obtain the device for evaluation.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.

• Brand Name: INTEGRITY TEMPGRIP
• Type of Device: DENTAL CEMENT
• Manufacturer (Section D): DENTSPLY CAULK; .; milford DE
• Manufacturer Contact: helen lewis ; 221 w.philadelphia st., ste 60 ; susquehanna commerce center; york, PA 17401 ; 7178457511
• MDR Report Key: 4943404
• MDR Text Key: 6038292
• Report Number: 2515379-2015-00047
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973201
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 06/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 666450
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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