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

Catalog Number 70098-001

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 10/26/2016

Event Type  Injury  

Manufacturer Narrative

The responsibly lies with the site/user/clinic to monitor how they handle the product and to perform any necessary investigations or reporting according to the site's procedures as to how an incident like that may have happened.Of course in a case like this where a (b)(6) child is involved, responsibility should also be shared with the parent present for the procedure.It is a circumstance entirely beyond hologic' s control.(b)(4).

Event Description

A customer in the united states reported that a (b)(6) child who visited the clinic with his mom, attempted to drink a vial of preservcyt solution left on the counter.The child spit it out right away.The mother immediately rinsed out the child's mouth.The child was observed for the rest of the day.Hologic's technical support forwarded material safety data (msds) for preservcyt solution to help them consider the most appropriate action.At this time no further issues have been reported about the boy.On 11/17/2016, it was reported "no further issues have been reported since i last talked to this caller.The boy i was told is fine".

• Brand Name: PRESERVECYT SOLUTION
• Type of Device: PRESERVATIVE
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: sidra piracha ; 250 campus drive; marlborough, MA 01752 ; 5082638884
• MDR Report Key: 6123984
• MDR Text Key: 60754625
• Report Number: 1222780-2016-00276
• Device Sequence Number: 1
• Product Code: MKQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P950039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 70098-001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/27/2016
• 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