MAUDE Adverse Event Report: HOLOGIC INC. PRESERVCYT SOLUTION; PRESERVATIVE

Device Problem Insufficient Information (3190)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 01/01/2014

Event Type  Injury  

Event Description

A customer in the us reported a (b)(6) year old patient (female) swallowed preservcyt solution.The customer has a copy of the material safety data sheet (msds) and hologic technical service instructed the customer to follow the instructions on the msds for ingestion.The customer indicated that they would and sent the child to the emergency room.No further info is available at this time.This is a reportable event in the us since ingesting preservcyt solution could result in a potentially serious injury or illness.

• Brand Name: PRESERVCYT SOLUTION
• Type of Device: PRESERVATIVE
• Manufacturer (Section D): HOLOGIC INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: eva maxwell ; 2 navigator rd; londonderry, NH 03053 ; 5082638922
• MDR Report Key: 4264604
• MDR Text Key: 19797073
• Report Number: 1222780-2014-00187
• Device Sequence Number: 1
• Product Code: MKQ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/05/2014

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: 10/09/2014
• Initial Date FDA Received: 11/07/2014
• 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: 2 YR