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 Problems Adhesion(s) (1695); Fever (1858); Fistula (1862); Nausea (1970); Other (for use when an appropriate patient code cannot be identified) (2200); Hernia (2240); Surgical procedure (2357); Obstruction/Occlusion (2422)

Event Type  Injury  

Event Description

It was reported by an attorney that the patient underwent a laparoscopic surgical procedure on (b)(6) 2012 and a mesh was implanted.It was reported that the patient experienced fever, constipation, nausea, noticed a bulge on the right side of her abdomen.On (b)(6) 2013, the patient was diagnosed by c-t scan with an obstructed bowel and adhesions.On (b)(6) 2014, the patient underwent surgery to repair the bowel obstruction and adhesions, and a piece of mesh was removed.The patient was diagnosed with another hernia on (b)(6) 2014.The patient was treated for a fistula in (b)(6) 2014.On (b)(6) 2014, the patient had a mesh removal surgery, and some of her symptoms have improved.No additional information was provided.

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 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 0151
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125, co; l salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: mary szaro ; route 22 west po box 151; somerville, NJ 08876 ; 9082183464
• MDR Report Key: 4910141
• MDR Text Key: 6051941
• Report Number: 2210968-2015-08330
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2015
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/20/2015
• 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