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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Date 01/01/2014

Event Type  Injury  

Event Description

A customer in the (b)(6) reported that a (b)(6) year old child may have ingested preservcyt solution and was seeking info on how to handle it.Hologic's key account manager (kam) forwarded the material safety data sheet (msds) for preservcyt solution to help them to consider the most appropriate action.The customer indicated that she doesn't think that the child ingested anything but arranged for him to go to the hospital as a precaution.No additional info has been reported at this time.Us: although it is not known if the child actually ingested preservcyt solution, this is a reportable event in the us since ingesting preservcyt solution could result in a potentially serious injury or illness.(b)(6): this is not a reportable event in the (b)(6).According to the (b)(4) guidelines, this event - if indeed there was an ingestion at all - would constitute abnormal use of the product and therefore would not be regarded as a reportable event.Our product comes with all the necessary precautions, labels and warnings and any case of ingestion of product would not relate at all to the intended use of the product.The responsibility 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 two-year old child is involved, responsibility should also be shared with the parent present for the procedure.It is a circumstance entirely beyond hologic's control.

• 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: 4257637
• MDR Text Key: 4993980
• Report Number: 1222780-2014-00202
• Device Sequence Number: 1
• Product Code: MKQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 11/14/2014

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: 10/29/2014
• Initial Date FDA Received: 11/14/2014
• 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