SCLERAL BUCKLING DEVICE UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-09-29 for SCLERAL BUCKLING DEVICE UNK manufactured by Unk.

Event Text Entries

[194167] A 51 yr old male with history of retinal detachment of the left eye which was repaired by way of scleral buckle. This procedure was done at another facility on 7/19/99. The pt was doing well but was noted to start complaining of double vision and pain in the left eye. He was observed for a period of time with no improvement in the symptoms. On 9/14/99 the pt underwent surgery for removal of scleral buckle left eye. Since the device was not put in at reporting facility rptr has no info concerning the device itself.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 242806
• MDR Report Key: 242806
• Date Received: 1999-09-29
• Date of Report: 1999-09-27
• Date of Event: 1999-09-14
• Date Facility Aware: 1999-09-14
• Report Date: 1999-09-27
• Date Added to Maude: 1999-10-05
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: BIOMEDICAL ENGINEER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SCLERAL BUCKLING DEVICE
• Generic Name: SCLERAL BUCKLE
• Product Code: HQJ
• Date Received: 1999-09-29
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 2 MO
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 235235
• Manufacturer: UNK
• Manufacturer Address: UNK UNK *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1999-09-29