3M? STERI-DRAPE? LARGE OPHTHALMIC DRAPE N/A 1065NS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-06-01 for 3M? STERI-DRAPE? LARGE OPHTHALMIC DRAPE N/A 1065NS manufactured by 3m Health Care.

Event Text Entries

[109831675] Patient info. Information was not provided. Lot number was not provided. Without a lot number, expiration date, manufacturer date and udi could not be determined. No sample has been received to date. This product is subject to sterilization by distributor who is the kit manufacturer. Multiple attempts have been made to obtain additional information for investigation of this reported event. End of report.
Patient Sequence No: 1, Text Type: N, H10


[109831678] A distributor notified 3m that a customer reported a patient experienced an "eye rash" allegedly associated with use of a 1065ns 3m? Steri-drape? Large ophthalmic drape. The patient was treated with oral cephalexin 500 mg 3 times daily, prednisolone 1% drops, topical bacitracin/polysporin and topical 1% hydrocortisone cream and the rash reportedly resolved.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2110898-2018-00060
MDR Report Key7561056
Report SourceDISTRIBUTOR
Date Received2018-06-01
Date of Report2018-06-01
Date of Event2018-05-01
Date Mfgr Received2018-05-17
Date Added to Maude2018-06-01
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 ContactDIANNE GIBBS
Manufacturer Street2510 CONWAY AVE 3M CENTER BUILDING 275-5W-06
Manufacturer CityST. PAUL MN 55144
Manufacturer CountryUS
Manufacturer Postal55144
Manufacturer Phone6517379117
Manufacturer G13M EDUMEX S.A. DE C.V.
Manufacturer Street6620 ORIENTE, CALLE RAMON RIVERA LARA, CD.
Manufacturer CityJUAREZ, CHIHUAHUA 32690
Manufacturer CountryMX
Manufacturer Postal Code32690
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name3M? STERI-DRAPE? LARGE OPHTHALMIC DRAPE
Generic NameSURGICAL DRAPE
Product CodePUI
Date Received2018-06-01
Model NumberN/A
Catalog Number1065NS
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
Manufacturer3M HEALTH CARE
Manufacturer Address2510 CONWAY AVE ST. PAUL MN 55144 US 55144


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-06-01

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