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 2000-04-19 for SCLERAL BUCKLING DEVICE UNK manufactured by Unk.

Event Text Entries

[191623] Pt had a scleral buckling procedure in 1999 at another facility, for retinal detachment. The pt has had several episodes of postop inflammation with recurrence of inflammatory tissue from the orbit, and multiple excisions of recurring tissue. On 4/4/00 the pt underwent removal of a 287 scleral buckle and a 240 band. The retina remained attached, but there was evidence of multiple areas of necrotic tissue and one area of red spongy type tissue that was dissected and sent to pathology.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 274721
• MDR Report Key: 274721
• Date Received: 2000-04-19
• Date of Report: 2000-04-17
• Date of Event: 2000-04-04
• Date Facility Aware: 2000-04-04
• Report Date: 2000-04-17
• Date Reported to FDA: 2000-04-17
• Date Added to Maude: 2000-04-25
• 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 Sequence Number: 1

• Brand Name: SCLERAL BUCKLING DEVICE
• Generic Name: SCLERAL BUCKLE DEVICE
• Product Code: LXP
• Date Received: 2000-04-19
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: 287 BUCKLE
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 11 MO
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 265906
• Manufacturer: UNK
• Manufacturer Address: UNK UNK UNK *

Device Sequence Number: 2

• Brand Name: SCLERAL BUCKLING DEVICE
• Generic Name: SCLERAL BUCKLE DEVICE
• Product Code: MTB
• Date Received: 2000-04-19
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: 240 BAND
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 11 MO
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 2
• Device Event Key: 265907
• Manufacturer: UNK
• Manufacturer Address: UNK UNK UNK *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2000-04-19