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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Tingling (2171)

Event Type  Injury  

Event Description

A customer in (b)(6) reported that a nurse with an alcohol allergy touched a thinprep preservcyt solution vial without realizing it.The nurse washed with running water but started to receive tingling pain and went to the hospital.It was reported that the patient did not get an allergic reaction.This is a reportable event in the us since an allergic reaction to thinprep 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 road; londonderry, NH 03053 ; 5082638922
• MDR Report Key: 5080137
• MDR Text Key: 25900432
• Report Number: 1222780-2015-00165
• Device Sequence Number: 1
• Product Code: MKQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2015
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other