RESURE SEALANT

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 2018-02-23 for RESURE SEALANT manufactured by Ocular Therapeutix.

Event Text Entries

[100883331] Despite multiple requests for additional information, ocular therapeutix (otx) has not received additional information. Otx does not have any information on the physician(s) who applied resure, the patients who may have experienced endophthalmitis, if serious injury occurred, or if the physician(s) believe resure sealant caused or contributed to the injury. Based on this information, there is insufficient information for us to determine if there is a change to the risk profile of resure. Follow-up reports will be submitted in accordance with 21 cfr part 803. 56 if additional information is obtained.
Patient Sequence No: 1, Text Type: N, H10


[100883332] In follow-up to a medical information request, a physician reported that there were two patients with endophthalmitis and both patients were treated with resure sealant. Otx was unable to collect additional information despite multiple attempts to follow-up with the physician.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008477155-2018-00002
MDR Report Key7293918
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2018-02-23
Date of Report2018-01-25
Date Mfgr Received2018-01-25
Date Added to Maude2018-02-23
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. ELIZABETH FENNA
Manufacturer Street15 CROSBY DRIVE
Manufacturer CityBEDFORD MA 01730
Manufacturer CountryUS
Manufacturer Postal01730
Manufacturer Phone7813574056
Manufacturer G1OCULAR THERAPEUTIX
Manufacturer Street36 CROSBY DRIVE SUITE 101
Manufacturer CityBEDFORD MA 01730
Manufacturer CountryUS
Manufacturer Postal Code01730
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRESURE SEALANT
Generic NameRESURE SEALANT
Product CodePFZ
Date Received2018-02-23
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerOCULAR THERAPEUTIX
Manufacturer Address36 CROSBY DRIVE SUITE 101 BEDFORD MA 01730 US 01730


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-02-23

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