MAUDE Adverse Event Report: ORMCO CORPORATION ZOO PACK ELASTICS

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Manufacturer Narrative

It was alleged that a patient had and allergic reaction; however no further specific information has been received at this time.An update will be provided upon receipt of new information.

Event Description

It was alleged that a patient had an allergic reaction to zoo pack elastics.

• Brand Name: ZOO PACK ELASTICS
• Type of Device: ZOO PACK ELASTICS
• Manufacturer (Section D): ORMCO CORPORATION; 1332 south lone hill avenue; glendora CA 91740
• Manufacturer (Section G): ORMCO CORPORATION; 1332 south lone hill avenue; glendora CA 91740
• Manufacturer Contact: suzette rampair-johnson ; 1332 south lone hill avenue; glendora, CA 91740 ; 9099625730
• MDR Report Key: 5448774
• MDR Text Key: 38640862
• Report Number: 2016150-2016-00001
• Device Sequence Number: 1
• Product Code: ECI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 02/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other