MAUDE Adverse Event Report: QIAGEN AMNISURE RAPID FETAL MEMBRANES RUPTURE TEST; IMMUNOASSAY FOR DETECTION OF AMNIOTIC FLUID PROTEIN(S)

Catalog Number FMRT1-25

Device Problem Difficult to Remove (1528)

Patient Problems Hemorrhage/Bleeding (1888); Device Embedded In Tissue or Plaque (3165)

Event Date 09/17/2019

Event Type  Injury  

Event Description

Aminisure done, when removed the cotton tip stayed inside, attempted to remove but unable to.Notified md, orders to do speculum exam, pt aware.Speculum exam completed with negative results.Possibly came out while pt was voiding and expelled some clots, bleeding resembling mucous plug.Fda safety report id# (b)(4).

• Brand Name: AMNISURE RAPID FETAL MEMBRANES RUPTURE TEST
• Type of Device: IMMUNOASSAY FOR DETECTION OF AMNIOTIC FLUID PROTEIN(S)
• Manufacturer (Section D): QIAGEN; germantown MD 20874
• MDR Report Key: 9172802
• MDR Text Key: 161835290
• Report Number: MW5090306
• Device Sequence Number: 1
• Product Code: NQM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2022
• Device Catalogue Number: FMRT1-25
• Device Lot Number: 56304378
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 30 YR
• Patient Weight: 49