MAUDE Adverse Event Report: ORMCO CORPORATION DAMON TMA

Catalog Number 227-1111

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Reaction (2414)

Event Date 10/10/2016

Event Type  Injury  

Manufacturer Narrative

It was alleged that a patient had an allergic reaction to damon tma wire.Attempts are being made to get further information will send an update.

Event Description

It was alleged that a patient had an allergic reaction to damon tma wires.Attempts are being made to get further information and will send an update.

Manufacturer Narrative

It was alleged that a patient had an allergic reaction to damon tma wire.Patient was sent to the er for treatment of allergic reaction.Tma wires were removed and replaced with stainless steel wires.To date the patient has recovered and doing fine.

Event Description

It was alleged that a patient had an allergic reaction to damon tma wires.

• Brand Name: DAMON TMA
• Type of Device: DAMON TMA
• Manufacturer (Section D): ORMCO CORPORATION; 1332 south lone hill ave.; glendora CA 91740
• Manufacturer (Section G): ORMCO CORPORATION; 1332 south lone hill ave.; glendora CA 91740
• Manufacturer Contact: suzette rampair-johnson ; 1332 south lone hill ave.; glendora, CA 91740 ; 9099625730
• MDR Report Key: 6031845
• MDR Text Key: 57556952
• Report Number: 2016150-2016-00005
• Device Sequence Number: 1
• Product Code: DZC
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 10/11/2016

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: Other
• Device Catalogue Number: 227-1111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/14/2016
• Initial Date FDA Received: 10/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 17 YR