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

Model Number 4350

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device batch pdb4841 and no non-conformances were identified.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: please clarify the actual damage with the two packages for example in one of the photos it looks like the peak pack is bent but it is difficult to see if the seal was impacted (opened) resulting in the two devices sterility being compromised? it is not certain that the package is completely damaged, but the product has obvious creases and the opening is obviously torn.How were the product stored? store at room temperature.Were the devices loose or something stored on the devices? a.No, they were not.What is the status of the devices being returned? we are waiting for the return of the sample if the devices were shipped for evaluation, provide the tracking number? it will be noted when the sample is shipped and a tracking number is generated.Confirm event occurred intraoperative? it is not used in surgery.Procedure device were going to be used in, if event occurred intraoperative? it is not used in surgery.

Event Description

It was reported that the patient underwent an unknown procedure on (b)(6) 2019 and the absorbable adhesive barrier was used.During the surgery, before used on the patient, it was noted the packing was damaged.Another device was used to complete the surgery.There were no adverse consequences reported.

Manufacturer Narrative

Date sent to the fda: 04/09/2020.Additional h-3 summary: only pictures were returned for analysis.Upon visual inspection of the pictures, samples of product code 4350 lot# pdb4841 with the flap damage could be observed.However, no conclusion could be reach on how this happen as the samples were not returned for analysis.

• Brand Name: GYNECARE INTERCEED 3INX4IN
• Type of Device: BARRIER, ABSORBABLE, ADHESION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9501671
• MDR Text Key: 175188857
• Report Number: 2210968-2019-91143
• Device Sequence Number: 1
• Product Code: MCN
• UDI-Device Identifier: 10705031005396
• UDI-Public: 10705031005396
• Combination Product (y/n): N
• PMA/PMN Number: P880047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 4350
• Device Catalogue Number: 4350
• Device Lot Number: PDB4841
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/29/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 04/01/2020
• Supplement Dates FDA Received: 04/09/2020
• Patient Sequence Number: 1