MAUDE Adverse Event Report: ETHICON INC. INTERCEED* (TC7) ABSORBABLE ADHESION BARRIER; BARRIER, ABSORBABLE, ADHESION

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4) date sent to the fda: 02/22/2016.(b)(4).If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.

Event Description

It was reported that a patient underwent a laparoscopic supracervical hysterectomy procedure on (b)(6) 2006 and an absorbable adhesion barrier was used.The patient reported that in 2012, they went to the emergency room with pain.An ultrasound was performed which revealed a large infection on the patient's cervical stump.The patient was admitted to the hospital and the infection was treated, but it was not stated how.In early 2015, the patient saw a doctor who performed tests and an unknown growth in her pelvis was found.On (b)(6) 2015, the patient had an additional procedure to remove the left ovary and remainder of the cervix.The patient discovered in early 2016 that the doctor reportedly discovered adhesions on the patient's right ovary during the procedure, but decided not to continue the surgery.On (b)(6) 2015, the patient went to the er for pain.On (b)(6) 2016, the patient had a color doppler ultrasound performed which showed active, live blood flow to the sight of the patient's right ovary.

• Type of Device: BARRIER, ABSORBABLE, ADHESION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): UNKNOWN; unknown; x
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 5451599
• MDR Text Key: 38709820
• Report Number: 2210968-2016-05290
• Device Sequence Number: 1
• Product Code: MCN
• Combination Product (y/n): N
• PMA/PMN Number: P880047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2016
• 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: 02/02/2016
• 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
• Treatment: MORCELLEX
• Patient Outcome(s): Required Intervention