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

Model Number 4350XL

Device Problems Product Quality Problem (1506); Contamination /Decontamination Problem (2895)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/04/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Attempts are being made to obtain the device.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 a patient underwent an unknown procedure on (b)(6) 2020 and an absorbable adhesion barrier was used.When opening the device packaging and unfolding the adhesion barrier, a foreign "eyelash" substance was found on the product.There were no adverse patient consequences.No further information were provided.

Manufacturer Narrative

(b)(4).Date sent to fda: 01/13/2021.H6 component code: g07002 - adhesion barrier.H3 analysis summary: during evaluation, the product was removed from its folder and unfolded.Both sides of the product was observed and as a result, no foreign matter "substance like an eyelash" was found to be adhered on the product.Product was found to be within quality requirements and compliant to its specification.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.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 inc, 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.

• 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
• MDR Report Key: 10601507
• MDR Text Key: 209030945
• Report Number: 2210968-2020-07450
• Device Sequence Number: 1
• Product Code: MCN
• UDI-Device Identifier: 10705031147843
• UDI-Public: 10705031147843
• 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: 09/09/2020

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 Model Number: 4350XL
• Device Catalogue Number: 4350XL
• Device Lot Number: QEB5691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Initial Date Manufacturer Received: 09/09/2020
• Initial Date FDA Received: 09/29/2020
• Supplement Dates Manufacturer Received: 01/07/2021
• Supplement Dates FDA Received: 01/13/2021
• Patient Sequence Number: 1