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

Device Problems Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191)

Patient Problems Abscess (1690); Adhesion(s) (1695); Erosion (1750); Fever (1858); Pain (1994); Perforation (2001); No Code Available (3191)

Event Date 03/15/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent to the fda: 11/06/2015.(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.This medwatch report is in response to receipt of maude event report mw5056509.

Event Description

It was reported that the patient underwent hysterectomy in 2015 and mesh was implanted.Following the procedure, the patient developed abdominal pain, pelvic pain, rectum pain and pressure.The patient was admitted in 2015 for abdominal pain and a hole in the abdomen and was discharged.In 2015, the patient was readmitted for the same issues including a high fever.The patient underwent a surgical procedure and mesh was found in the vagina.A central perforation was found of approximately 1 cm at the apex of the vagina with extrusion of mesh through the central perforation.The extruded mesh was removed in full.The patient underwent another surgical procedure in 2015 and it was reported that the surgeon noted fluid in the pelvis, consisting of pelvic abcess and bowel prolapse.Some adhesions were found on the small bowel and had stacked on top of the vaginal path and were removed by the surgeon to clear the vaginal path.No additional information was provided.

• 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: 5207861
• MDR Text Key: 30627907
• Report Number: 2210968-2015-17799
• 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
• Report Date: 10/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/22/2015
• Initial Date FDA Received: 11/06/2015
• 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): Hospitalization; Required Intervention