CIRCLING BAND 240-STYLE 2.5 E5381700

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-01-09 for CIRCLING BAND 240-STYLE 2.5 E5381700 manufactured by Storz Instrument Company.

Event Text Entries

[92733] This band broke while the physician was performing a scleral buckle procedure. He finished the procedure using another band.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1920664-1998-00007
MDR Report Key143710
Report Source05,06
Date Received1998-01-09
Date of Report1997-12-10
Date of Event1997-12-10
Date Facility Aware1997-12-10
Report Date1997-12-10
Date Reported to Mfgr1997-12-10
Date Mfgr Received1997-12-10
Device Manufacturer Date1997-09-01
Date Added to Maude1998-01-15
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Remedial ActionRC
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCIRCLING BAND 240-STYLE 2.5
Generic NameIMPLANT FOR RETINAL DETACHMENT SURGERY
Product CodeHQX
Date Received1998-01-09
Model NumberNA
Catalog NumberE5381700
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age2 MO
Device Eval'ed by MfgrY
Implant FlagY
Date RemovedA
Device Sequence No1
Device Event Key140165
ManufacturerSTORZ INSTRUMENT COMPANY
Manufacturer Address3365 TREE COURT IND BLVD ST. LOUIS MO 63122 US
Baseline Brand NameCIRCLING BAND 240-STYLE 2.5
Baseline Generic NameIMPLANT FOR RETINAL DETACHMENT SURGERY
Baseline Model NoNA
Baseline Catalog NoE5381700
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
10 1998-01-09

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.