MAUDE Adverse Event Report: GAC INTERNATIONAL ELF LATEX FREE ELASTICS

Catalog Number 11/200/16

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Reaction (2414)

Event Type  Injury  

Event Description

In this event a patient experienced an allergic reaction from an elastomeric used after its expiration date, they reported swelling and irritation to the gingiva and cheek.Medical attention was necessary as the patient was prescribed a steroid.

Manufacturer Narrative

While it is unknown if the elastometric 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.Evaluation of the device found that the product expired in 12/2005.

• Brand Name: ELF LATEX FREE ELASTICS
• Manufacturer (Section D): GAC INTERNATIONAL; islandia NY
• Manufacturer Contact: helen lewis ; susquehanna commerce center w; 221 w philadelphia st, ste 60; york, PA 17401 ; 7178457511
• MDR Report Key: 3894081
• MDR Text Key: 15998549
• Report Number: 2418500-2014-00001
• Device Sequence Number: 1
• Product Code: ECI
• 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: 05/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2005
• Device Catalogue Number: 11/200/16
• Device Lot Number: 03-42
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/28/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR