MAUDE Adverse Event Report: ETHICON BLAKE; SILICONE DRAIN

Model Number 2227

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/07/2018

Event Type  malfunction  

Event Description

Drain was removed on (b)(6) 2018.Patient returned on (b)(6) 2018 with bleeding and it was found that a piece of the drain was in the wound.Patient underwent surgery for revision/reimplantation right total knee arthroplasty.Fda ref # (b)(4).Dates of use: (b)(6) 2018.Event abated after use stopped or dose reduced: yes.

• Brand Name: BLAKE
• Type of Device: SILICONE DRAIN
• Manufacturer (Section D): ETHICON; somerville NJ
• MDR Report Key: 7273343
• MDR Text Key: 100425472
• Report Number: MW5075270
• Device Sequence Number: 1
• Product Code: GBX
• 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: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2227
• Device Catalogue Number: 2227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Weight: 98