MAUDE Adverse Event Report: ETHICON INC. SECURESTRAP; IMPLANTABLE STAPLE

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problems Hernia (2240); Surgical procedure (2357)

Event Type  Injury  

Event Description

It was reported that a patient underwent a hernia repair procedure on an unknown date and straps were used to fixate the mesh.The straps tore the mesh and the patient experienced a recurrence of the hernia.The patient underwent another surgical procedure.

Manufacturer Narrative

(b)(4).Conclusion: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.

• Brand Name: SECURESTRAP
• Type of Device: IMPLANTABLE STAPLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): ETHICON INC. - JUAREZ; avenida de las torres 7125, co; l salvacar; ciudad juarez 3260 4; MX 32604
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 3761308
• MDR Text Key: 4415341
• Report Number: 2210968-2014-05068
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K093845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/26/2014
• 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): Required Intervention