MAUDE Adverse Event Report: ETHICON INC. SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE; STAPLE, IMPLANTABLE

Catalog Number STRAP25

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

Patient Problem Bleeding (1738)

Event Date 05/20/2015

Event Type  Injury  

Event Description

It was reported that the patient underwent an incisional hernia repair procedure on unknown date and absorbable straps were used.During the procedure, bleeding occurred and hemostasis was used to control.Another like device was used to complete the procedure.Additional information has been requested.

Manufacturer Narrative

(b)(4).Conclusion: to date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.

• Brand Name: SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE
• Type of Device: STAPLE, IMPLANTABLE
• 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: mary szaro ; route 22 west po box 151; somerville, NJ 08876 ; 9082183464
• MDR Report Key: 4842050
• MDR Text Key: 5936630
• Report Number: 2210968-2015-07045
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 05/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: STRAP25
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/20/2015
• Was Device Evaluated by Manufacturer?: No
• 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