MAUDE Adverse Event Report: ORMCO CORPORATION FACEBOW

Catalog Number 200-0221

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 10/23/2017

Event Type  Injury  

Manufacturer Narrative

It was alleged that a patient had an allergic reaction to the facebow; however no further specific information has been received at this time.Attempts are being made to get further information and will an update.

Event Description

It was alleged that a patient had an allergic reaction to facebow.

Manufacturer Narrative

The product involved in the alleged incident was returned and evaluated.The product met specifications and packaging warns of product containing nickle and chromium and should not be used on individuals with allergic sensitivity to these metals.To date the patient is doing better.

• Brand Name: FACEBOW
• Type of Device: FACEBOW
• Manufacturer (Section D): ORMCO CORPORATION; 1332 south lone hill ave.; glendora CA 91740
• Manufacturer (Section G): ORMEX S. DE R.L. DE C.V.; calle 21 no 1103; amp cd industrial; uman, yucatan CA 97390 ; MX 97390
• Manufacturer Contact: suzette rampair-johnson ; 1332 south lone hill ave.; glendora, CA 91740 ; 9099625730
• MDR Report Key: 7005152
• MDR Text Key: 91185802
• Report Number: 2016150-2017-00005
• Device Sequence Number: 1
• Product Code: DZB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Service Personnel
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 200-0221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 10 YR