RELEX SMILE APPARATUS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-09 for RELEX SMILE APPARATUS manufactured by Unk.

Event Text Entries

[82593621] Relex smile surgery, both eyes. Tried to solve astigmatism but led to severe dry eye and corneal denevation. Still suffering refractive dysfunction.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5071525
• MDR Report Key: 6787697
• Date Received: 2017-08-09
• Date of Report: 2017-08-09
• Date of Event: 2016-11-10
• Date Added to Maude: 2017-08-11
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 0

• Brand Name: RELEX SMILE APPARATUS
• Generic Name: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Product Code: OTL
• Date Received: 2017-08-09
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: UNK

Device Sequence Number: 1

• Brand Name: RELEX SMILE APPARATUS
• Generic Name: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Product Code: KDD
• Date Received: 2017-08-09
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: UNK

Device Sequence Number: 2

• Brand Name: RELEX SMILE APPARATUS
• Generic Name: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Product Code: KDD
• Date Received: 2017-08-09
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: UNK

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening; 2. Deathisabilit	2017-08-09