MAUDE Adverse Event Report: ETHICON INC. GYNECARE INTERCEED 5INX6IN; BARRIER, ABSORBABLE, ADHESION

Model Number 4350XL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Additional information was requested, and the following was obtained: "date and indication of initial surgical procedure? no further information is available.Were there any intra-op complications? no further information is available.Did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? no further information is available.Other relevant patient comorbidities/concomitant medications? no further information is available.What medical intervention was given for the pain management? results? puncture suction was done, then, brown material was suctioned.After puncture suction was done twice, the patient recovered.Onset date of accumulation from the initial surgery? no further information is available.Diagnostic confirmation of accumulation? no further information is available.Nature and character of accumulation? no further information is available.Please clarify what does ¿accumulation of something¿ mean? no further information is available.Were there any culture tests performed? results? no further information is available.What is physician¿s opinion as to the etiology of or contributing factors to this event? the doctor commented, ""there may have been an infection."" does the surgeon believe that interceed causes this ¿accumulation of something¿? no further information is available.What is the patient's current status? after puncture suction was done twice, the patient recovered.Product lot number? the lot number is unknown.The patient demographic info: age, gender, weight, bmi at the time of index procedure?"" no further information is available.No further information will be provided.

Event Description

It was reported that the patient underwent an unknown digestive surgery on unknown date and the absorbable adhesive barrier was used.A month after the surgery, the patient complained of abdominal pain.It was also reported that accumulation of something was observed directly under the abdominal wall.Puncture suction was done, then, brown material was suctioned.After puncture suction was done twice, the patient recovered.The doctor opined that there may have been an infection.No further information is available.

• Brand Name: GYNECARE INTERCEED 5INX6IN
• Type of Device: BARRIER, ABSORBABLE, ADHESION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR ; *
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9827891
• MDR Text Key: 183289704
• Report Number: 2210968-2020-02014
• Device Sequence Number: 1
• Product Code: MCN
• UDI-Device Identifier: 10705031147843
• UDI-Public: 10705031147843
• 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
• Report Date: 02/19/2020

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
• Device Model Number: 4350XL
• Device Catalogue Number: 4350XL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2020
• Initial Date FDA Received: 03/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention