MAUDE Adverse Event Report: INTEGRA YORK, PA INC. PESARY CUBE W/DRAIN SZ4 41MM; M7 - OB-GYN

Catalog Number 30-CUD4

Device Problem Fluid/Blood Leak (1250)

Patient Problems Hemorrhage/Bleeding (1888); Discomfort (2330)

Event Date 09/28/2018

Event Type  Injury  

Manufacturer Narrative

The device was not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A patient reported to integra that on (b)(6) 2018, a 30-cud4 pesary cube w/drain has caused discomfort, bleeding and leakage.The device was in contact with the patient.Revision or medical intervention was required.Patient was not prepped for surgery.No surgery delay were reported.Additional information has been requested.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation, therefore the failure mode cannot be confirmed.Root cause cannot be determined due to the lack of information received to perform a complete investigation.There were no deviations or non-conformances during the manufacturing process.

• Brand Name: PESARY CUBE W/DRAIN SZ4 41MM
• Type of Device: M7 - OB-GYN
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• MDR Report Key: 7970091
• MDR Text Key: 123865905
• Report Number: 2523190-2018-00127
• Device Sequence Number: 1
• Product Code: HHW
• Combination Product (y/n): N
• PMA/PMN Number: K092981
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Operator: Health Professional
• Device Catalogue Number: 30-CUD4
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/28/2018
• Initial Date FDA Received: 10/16/2018
• Supplement Dates Manufacturer Received: 10/30/2018
• Supplement Dates FDA Received: 11/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1