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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Pain (1994); Scarring (2061); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4) additional surgical procedure.To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.

Event Description

It was reported by an attorney that the patient underwent gynecological procedure on (b)(6) 2009 and an absorbable adhesion barrier was used.It was reported that she experienced pain, erosion of her internal bodily tissue and other injuries following the procedure.It was reported that the patient has undergone multiple surgeries and revisionary procedures.ࠎo additional information was provided.

Manufacturer Narrative

It was reported that following insertion the patient experienced recurrence, urinary problems, dyspareunia and vaginal scarring.

• 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): ETHICON INC.-PENDING DETERMINATION; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer Contact: kenneth clark ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183547
• MDR Report Key: 5995951
• MDR Text Key: 56333070
• Report Number: 2210968-2016-14195
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2017
• 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
• Treatment: TVT-O, INTERCEED, COLOPLAST RESTORELLE
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR