STORZ CIRCLING BAND (240 STYLE) E5381 700

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 1996-08-30 for STORZ CIRCLING BAND (240 STYLE) E5381 700 manufactured by Storz Instrument Co.

Event Text Entries

[20855] Since implantation of these extra-ocular bands beginning in 4/96, five pts have suffered tremendous inflammatory reaction, restricted mobility and exophthalmos. The circling bands were explanted and the pts reimplanted with another circling band. On the sixth day there was the disappearance of pain and inflammation. The circling band was examined in the bacteriological department. No infections were found: the circling bands being used are of two different colors: one is blue and the other has a "yellow" shine. The bands with the blue shine were involved in the reported incdients.
Patient Sequence No: 1, Text Type: D, B5


[16495787] Summarization of cytotoxicity tests are as follows: sample e5381-700 lot 261038345 identified as "blue" and "problem": grade/reactivity: 0/none, conclusion: not cytotoxic. Sample e5381-700 lot 149035276 identified as "yellow" and "no problem": grade/reactivity: 1/slight, conclusion: not cytotoxic. Sample e5381-700 part representing current inventory: grade/reactivity: 0/none, conclusion: not cytotoxic.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1920664-1996-00597
MDR Report Key36890
Report Source05,06
Date Received1996-08-30
Date of Report1996-08-02
Date of Event1996-04-01
Report Date1996-08-02
Date Reported to Mfgr1996-08-02
Date Mfgr Received1996-08-02
Date Added to Maude1996-09-10
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
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSTORZ CIRCLING BAND (240 STYLE)
Generic NameEXTRA OCULAR ORBITAL IMPLANT
Product CodeHQX
Date Received1996-08-30
Model NumberNA
Catalog NumberE5381 700
Lot Number261038345
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age5 MO
Device Eval'ed by MfgrN
Implant FlagY
Date RemovedA
Device Sequence No1
Device Event Key38281
ManufacturerSTORZ INSTRUMENT CO
Manufacturer Address3365 TREE COURT IND BLVD ST LOUIS MO 63122 US
Baseline Brand NameSTORZ CIRCLING BAND (240 STYLE)
Baseline Generic NameEXTRA OCULAR ORBITAL IMPLANT
Baseline Model NoNA
Baseline Catalog NoE5381 700
Baseline IDNA
Baseline Device FamilyRETINAL DETACHMENT IMPLANTS
Baseline Shelf Life ContainedA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK832481
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 1996-08-30

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