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

Catalog Number 70098-001

Device Problem Use of Device Problem (1670)

Patient Problem Injury (2348)

Event Date 01/31/2016

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 us reported a (b)(6) "drank" preservcyt solution.The customer has a copy of the material safety data sheet (msds) and "the child was taken to the hospital".No further information is available at this time.

• 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: 6371798
• MDR Text Key: 68781616
• Report Number: 1222780-2017-00047
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 01/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 70098-001
• Device Lot Number: UNKONWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2017
• 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): Hospitalization