MAUDE Adverse Event Report: COOK INC COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS; KNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC

Catalog Number J-SOSR-100500

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.

Event Description

It was reported that on multiple occasions with different patients, the balloon had fallen out of the patient while filled with 300-500cc's of fluid.It was also reported that some of these events were resolved by using a different device, but others required a hysterectomy.It was confirmed that none of the patients had any further injuries or complications aside from the hysterectomies.

• Brand Name: COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS
• Type of Device: KNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 7224139
• MDR Text Key: 98411959
• Report Number: 1820334-2018-00305
• Device Sequence Number: 1
• Product Code: KNA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/29/2018

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: Health Professional
• Device Catalogue Number: J-SOSR-100500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2018
• Initial Date FDA Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other