MAUDE Adverse Event Report: GAC INTERNATIONAL GAC NON LETEC ELESTICS; BAND, ELASTIC, ORTHODONTIC

Catalog Number 11-303-03

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Burning Sensation (2146)

Event Type  Injury  

Event Description

In this event it was reported that between two or three weeks after exposure to gac elastics (non-latex), a pt began experiencing buring and itching of the lips and eyes.The pt took benadryl to combat the symptoms.

Manufacturer Narrative

While it is unk if the device used in this case caused or contributed to the pt'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 responses and subsequent exposure to the same material.Therefore, this event meets the criteria for reportability per 21 cfr park 803.The device is available for eval, though results are not available as of this report.Eval results will be submitted as they become available.

• Brand Name: GAC NON LETEC ELESTICS
• Type of Device: BAND, ELASTIC, ORTHODONTIC
• Manufacturer (Section D): GAC INTERNATIONAL; islandia NY
• Manufacturer Contact: helen lewis ; 221 w philadelphia st, ste 60; susquehanna commerce ctr w; york, PA 17401 ; 7178457511
• MDR Report Key: 4795832
• MDR Text Key: 5855996
• Report Number: 2418500-2015-00001
• 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: 04/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2016
• Device Catalogue Number: 11-303-03
• Device Lot Number: 316739
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/21/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2015
• Was Device Evaluated by Manufacturer?: No
• 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