SCLERAL BUCKLING PRODUCTS: STYLE 506, 3.0MM X 5.0MM OVAL SPONGE 92-50-5

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-06-11 for SCLERAL BUCKLING PRODUCTS: STYLE 506, 3.0MM X 5.0MM OVAL SPONGE 92-50-5 manufactured by Dutch Opthalmic Research Center Bv.

Event Text Entries

[110703553] The investigation has begun. Device history lot review: there was nothing relative to this complaint. This lot met both sterility and bacterial endotoxin test reports. Results pass requirements. Unused samples were returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10


[110703554] A user facility has reported a surgical removal of an eye implant due to infection and extrusion. The initial date of surgery for a retinal detachment occurred on (b)(6) 2017 for placement of this device. Then on (b)(6) 2018 the scleral buckle was removed for infection and extruding. The device was removed and then sent to pathology. It was reported pathology report indicated occasional gram + cocci. The patient was treated with antibiotics. The incident has fully resolved. The facility has returned unused samples from this lot for evaluation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1222074-2018-00174
MDR Report Key7588927
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2018-06-11
Date of Report2018-05-18
Date of Event2018-02-19
Date Mfgr Received2018-08-02
Device Manufacturer Date2017-07-25
Date Added to Maude2018-06-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS LAURA SMITH
Manufacturer Street10 CONTINENTAL DR BLDG 1
Manufacturer CityEXETER NH 03833
Manufacturer CountryUS
Manufacturer Postal03833
Manufacturer Phone6037786929
Manufacturer G1DUTCH OPTHALMIC RESEARCH CENTER BV
Manufacturer StreetSCHEIJDELVEWEG 2
Manufacturer CityZUIDLAND, 3214VN
Manufacturer CountryNL
Manufacturer Postal Code3214VN
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSCLERAL BUCKLING PRODUCTS: STYLE 506, 3.0MM X 5.0MM OVAL SPONGE
Generic NameSCLERAL BUCKLING PRODUCTS: STYLE 506, 3.0MM X 5.0MM OVAL SPONGE
Product CodeHQX
Date Received2018-06-11
Returned To Mfg2018-07-03
Catalog Number92-50-5
Lot Number1007046
OperatorPHYSICIAN
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDUTCH OPTHALMIC RESEARCH CENTER BV
Manufacturer AddressSCHEIJDELVEWEG 2 ZUIDLAND, 3214VN NL 3214VN


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-06-11

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