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

Lot Number ASKU

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Adhesion(s) (1695); Pain (1994); Discharge (2225); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent to fda: 10/06/2016.(b)(4).Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.How are you currently feeling? please provide your age, body weight and height at the time of this surgical procedure.If in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? to date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that the patient underwent robotic oophorectomy and hysterectomy procedure in (b)(6) 2015 and an absorbable adhesion barrier was implanted.The patient reported that two and a half weeks after the procedure, she experienced water discharging from her vagina for 3 days, pain, and silver nitrate granulation in her vagina.The patient had a second follow up procedure in (b)(6) 2016 which found that part of her colon had attached to the vaginal cuff.There were more adhesions found and endometriosis.The surgeon "cleaned her out" during this second procedure.The patient reports that she is still experiencing pain since this second procedure.Additional information has been requested.

• 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: kenneth clark ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183547
• MDR Report Key: 6002853
• MDR Text Key: 56583495
• Report Number: 2210968-2016-14230
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2016
• 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
• Patient Outcome(s): Required Intervention