SCLERAL BUCKLING PRODUCTS: STYLE 70, SILICONE SLEEVE 92-13

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-16 for SCLERAL BUCKLING PRODUCTS: STYLE 70, SILICONE SLEEVE 92-13 manufactured by D.o.r.c Dutch Ophthalmic International Bv.

Event Text Entries

[102716101] Lot review: there is nothing relative to the complaint. The material used is medical grade implantable silicone. After testing the root cause is inconclusive for an allergic reaction. This complaint is considered an isolated incident. Sample analysis: no sample was received. Conclusion: the complaint is not confirmed. This reportable event was identified during a voluntary retrospective review of all complaints since 2015 by the manufacturer (dutch ophthalmic research centre b. V. ). Details of this activity were discussed with cdrh office of compliance (b)(6) during a tele-conference on (b)(6)2017. All available information has been disclosed. This complaint has now been closed. Please note that 2 mdrs submitted for the 2 parts that were used together in the implant 1222074-2018-00052 and 1222074-2018-00053.
Patient Sequence No: 1, Text Type: N, H10


[102716102] It was reported a patient had a scleral buckle implanted in right eye one year ago. The patient reportedly had an allergic reaction on the skin surrounding her eye and was seen by a dermatologist. The patient was evaluated for a possible allergic reaction related to silicone. It was reported the md wants to perform an allergy test.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1222074-2018-00053
MDR Report Key7346826
Date Received2018-03-16
Date of Report2015-02-04
Date of Event2015-02-04
Date Mfgr Received2015-02-04
Date Added to Maude2018-03-16
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
Manufacturer CityEXETER NH 03833
Manufacturer CountryUS
Manufacturer Postal03833
Manufacturer Phone6037538824
Manufacturer G1D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV
Manufacturer StreetSCHEIJDELVEWEG 2
Manufacturer CityZUIDLAND, NETHERLANDS
Manufacturer CountryNL
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameSCLERAL BUCKLING PRODUCTS: STYLE 70, SILICONE SLEEVE
Generic NameSCLERAL BUCKLING PRODUCTS: STYLE 70, SILICONE SLEEVE
Product CodeHQX
Date Received2018-03-16
Catalog Number92-13
Lot Number161019
OperatorPHYSICIAN
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerD.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV
Manufacturer AddressSCHEIJDELVEWEG 2 ZUIDLAND, NETHERLANDS NL


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-03-16

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