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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC INC. CYTOLYT SOLUTION
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HOLOGIC INC. CYTOLYT SOLUTION Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Date 01/01/2015
Event Type  Injury  
Event Description
A nurse from the (b)(6) reported a (b)(6) (boy) ingested half of a vial cytolyt solution.Hologic's technical service personnel provided the nurse with the concentration of methanol in vial.Nurse reported that the child is being treated at a hospital and that the incident took place at a dr's office.Hologic's technical service personnel followed up with nurse.The child was given a blocking agent and checked for methanol level.Methanol level proved to be negative and the child was discharged from hospital.This is a reportable event in the united states since ingesting cytolyt solution could result in a potentially serious injury or illness.
 
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Brand Name
CYTOLYT SOLUTION
Type of Device
CYTOLYT
Manufacturer (Section D)
HOLOGIC INC.
250 campus drive
marlborough MA 01752
Manufacturer Contact
eva maxwel
2 navigator road
londonderry, NH 03053
5082638922
MDR Report Key4944954
MDR Text Key6040872
Report Number1222780-2015-00131
Device Sequence Number1
Product Code MKQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Unknown
Reporter Occupation Nurse
Type of Report Initial
Report Date 07/24/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/29/2015
Initial Date FDA Received07/24/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age2 YR
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