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Adverse Event Report

BD OPHTHALMIC SYSTEMS GENTIAN MARKING PAD BD VISIMARK VIOLET MARKING PAD   back to search results
Catalog Number 581057
Event Type  Other   Patient Outcome  Other;
Event Description

The account thinks the marking pads cuased dlk in 7 cases in 8/2003.

 
Manufacturer Narrative

Note: customer is running an investigation on all items used in procedure to troubleshoot cause of dlk. Investigation in-process.

 
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Brand NameGENTIAN MARKING PAD
Type of DeviceBD VISIMARK VIOLET MARKING PAD
Baseline Brand NameBD VISIMARK GENTIAN VIOLET MARKING PAD
Baseline Generic NameMD VISIMARK GENTIAN MARKING PAD
Baseline Catalogue Number581057
Baseline Device FamilyBD VISITEC PRE-INKED MARKING PADS
Baseline Device 510(K) NumberK884718
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed11/23/1988
Manufacturer (Section F)
BD OPHTHALMIC SYSTEMS
411 waverley oaks road
bldg. 2, suite 229
waltham MA 02452
Manufacturer (Section D)
BD OPHTHALMIC SYSTEMS
411 waverley oaks road
bldg. 2, suite 229
waltham MA 02452
Manufacturer Contact
pat filosa
411 waverley oaks road
bldg. 2, suite 229
waltham , MA 02452
Device Event Key483339
MDR Report Key494627
Event Key468981
Report Number1211998-2003-00003
Device Sequence Number1
Product CodeHMQ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/11/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date06/30/2008
Device Catalogue Number581057
Device LOT Number3155268
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer08/21/2003
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/13/2003
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/01/2003
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on January 30, 2009

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