MAUDE Adverse Event Report: HOLOGIC INC CYTOLYT SOLUTION; PRESERVATIVE

Device Problems Improper or Incorrect Procedure or Method (2017); Human-Device Interface Problem (2949)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2014

Event Type  Injury  

Event Description

A customer in italy reported a (b)(6) year old patient (woman) swallowed cytolyt solution during an examination.The pt was transferred to the toxicology department in another hospital.It was reported that there is no report of vial or cap manufacturing issues.This incident was found to be caused by negligence on the part of the treating office.After treatment it was reported that the pt was healthy.

• Brand Name: CYTOLYT SOLUTION
• Type of Device: PRESERVATIVE
• Manufacturer (Section D): HOLOGIC INC; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): HOLOGIC INC.; 2 navigator road; londonderry NH 03053
• Manufacturer Contact: eva maxwell ; 5082638922
• MDR Report Key: 3709228
• MDR Text Key: 4332136
• Report Number: 1222780-2014-00052
• Device Sequence Number: 1
• Product Code: MKQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 93 YR