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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abscess (1690); Fever (1858); Not Applicable (3189)

Event Date 12/23/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The actual device batch number associated with this event is not known.The international affiliate reports the following possible batch numbers: batch (b)(4), batch (b)(5).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 laparoscopic dermoid ovarian cyst removal on (b)(6) 2017 and adhesion barrier was applied to the ovary after the ovarian cyst was resected.On (b)(6) 2017, the patient had a fever of 39 degrees celsius and fever did not go down through antibiotics administered.Abscess was observed by ct images and on (b)(6) 2017, the abscess was removed.Infection was not observed and the result of cultivation was negative, accumulation of pus was not observed.Fibrous material was observed in the abscess.The patient was administered antibiotics after removal of the abscess and on (b)(6) 2017 the drain was removed.The surgeon opined the contributing factor was not the device only and the event was caused by multiple factors.The patient has been discharged from the hospital.No additional information was provided.

Manufacturer Narrative

Pc-000097608 additional information: ¿ the actual device batch number associated with this event is not known.The international affiliate reports the following possible batch numbers: batch lgb7321; mfg.Date - (b)(6) 2017; exp.Date - (b)(6) 2022 batch keb4911, mfg.Date - (b)(6) 2015; exp.Date - (b)(6)2020 in addition, a review of the batch manufacturing records for the possible batch numbers was conducted and the batches met all finished goods release criteria.

• Brand Name: INTERCEED (TC7) UNKNOWN PRODUCT
• Type of Device: BARRIER, ABSORBABLE, ADHESION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON INC.; road 183, km. 8.3; san lorenzo
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 7230820
• MDR Text Key: 98669722
• Report Number: 2210968-2018-70554
• Device Sequence Number: 1
• Product Code: MCN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P880047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• 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: 02/09/2018
• 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