MAUDE Adverse Event Report: COOK BIOTECH ¿ZENAPRO HYBRID HERNIA REPAIR GRAFT; HYBRID GRAFT

Catalog Number UNKNOWN

Device Problems Improper or Incorrect Procedure or Method (2017); Improper Device Output (2953)

Patient Problem No Code Available (3191)

Event Date 06/05/2017

Event Type  Injury  

Manufacturer Narrative

Lot number not provided by the complainant.Product expire date unknown; lot number not provided.Product manufacture date unknown; lot number not provided.Product catalog number unknown, product unspecified.Implant date only specified as (b)(6) 2017.The lot number was not provided; therefore, a review of device history was not performed.Seroma formation is listed as one of the potential complications noted in the ifu.According to the ifu, the user should ¿place closed suction drains for 2-6 weeks.Remove when output is less than 20 ml/24 hours for at least two (2) consecutive days or until drain is dry.The root cause, of the patient¿s large fluid collection, may be related to the premature removal of one of the drains.However, seroma formation is a known inherent risk of the surgical procedure.

Event Description

In (b)(6) 2017, dr.(b)(6) placed a zenapro, in an onlay fashion, for an awr (abdominal wall reconstruction) and hernia repair.Dr.(b)(6) placed two (2) drains at the time of the procedure.One drain was removed prematurely by the patient.The second drain was removed by dr.(b)(6) after it had only 30 cc of output for forty-eight (48) hours.At the end of (b)(6), the patient developed a large fluid collection.On (b)(6) 2017, the patient was admitted to the hospital after arriving at the emergency room with a large fluid collection.The plan was for radiology to drain the fluid.On 06/20/2017, dr.(b)(6) indicated, to his local cook area representative, that the patient was doing okay.Based on the email, the patient did undergo some sort of fluid drainage, but additional details are unknown.

• Brand Name: ¿ZENAPRO HYBRID HERNIA REPAIR GRAFT
• Type of Device: HYBRID GRAFT
• Manufacturer (Section D): COOK BIOTECH; 1425 innovation place; west lafayette IN 47906
• Manufacturer Contact: perry guinn ; 1425 innovation place; west lafayette, IN 47906 ; 7654973355
• MDR Report Key: 6678494
• MDR Text Key: 78766979
• Report Number: 1835959-2017-00003
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention