MAUDE Adverse Event Report: ETHICON INC. GYNECARE INTERCEED 3INX4IN; BARRIER, ABSORBABLE, ADHESION

Model Number	4350
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abscess (1690)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(b)(4).If further details are received at a later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: what is the procedure name and initial procedure date? was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.What is the most current patient status? can you identify the lot number of the product that was used? the product was used for laparoscopic total hysterectomy, and the sites of use are the ovary and the uterine stump.Abscess occurred at the application site of the product.The patient was admitted to the hospital after the abscess developed, and the symptoms were improved by administering antibiotics for 3 days.The patient's condition was normal thereafter, and the patient was already discharged from the hospital.
Event or Problem Description
It was reported that a patient underwent a total laparoscopic hysterectomy on an unknown date and the absorbable, adhesion barrier was used.It was reported that the patient developed a postoperative abscess at the application site of the device.The patient was admitted to the hospital after the abscess developed, and the symptoms were improved by administering antibiotics for three days.The patient's condition was normal thereafter, and the patient was discharged from the hospital.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 09/21/2021.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc., or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information was requested and the following was obtained: the patient demographic info: age, weight, bmi at the time of index procedure.No further information is available.Date of initial surgical procedure: no further information is available.What are the patient comorbidities/concomitant medications? no further information is available.Date - time of onset of abscess from the surgical procedure? 2 weeks after.Were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? no further information is available.Did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? after the fever, antibiotic treatment continued for 3 days.Were cultures performed? results? no further information is available.Product lot # no further information is available.What is physician¿s opinion as to the etiology of or contributing factors to this event? although it is not clear whether there is direct involvement, it seems that there is a recognition that interceed is more likely to cause abscess than seprafilm than before.It is possible that bacteria from the outside invaded through the gaps in the stump of the uterus.What is the patient's current status? symptoms improved after 3 days of antibiotic administration and the patient was already discharged.No further information will be provided.

• Brand Name: GYNECARE INTERCEED 3INX4IN
• Common Device Name: BARRIER, ABSORBABLE, ADHESION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12351227
• Report Number: 2210968-2021-07576
• Device Sequence Number: 1180423
• Product Code: MCN
• UDI-Device Identifier: 10705031005396
• UDI-Public: 10705031005396
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P880047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2021

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
• Operator of Device: Health Professional
• Device Model Number: 4350
• Device Catalogue Number: 4350
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/26/2021
• Supplement Date Received by Manufacturer: 08/22/2021
• Initial Report FDA Received Date: 08/20/2021
• Supplement Report FDA Received Date: 09/21/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention