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

Model Number	4350
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Photo analysis summary: four pictures were received for evaluation.Upon to visual inspection of the pictures the following could be noted: first picture: an overwrap packet identified with lot # qbb2061 and exp date on 2024-07-31 was observed with a blue note stick without print information.The blue note stick is not coming from our process because the design is not used during the manufacturing process.The barcodes were scanned in a qr and the results obtained from the packaging is consistent with the lot number.(01107050310053961724073110qbb2061).Second picture: a sealed box identified with product code 4350, lot # qbb2061 and exp date 2024-07-31 the barcodes were scanned in a qr and the results obtained from the packaging is consistent with the lot number (01207050310053931724073110qbb2061).Third picture: a sealed box identified with product code 4350, lot # qbb2061, the picture shows a comparison of two labels, one of them is reversed, on the label adherence to box the information is not clear when the picture is visually inspected.Fourth picture: a foil packet identified with product code 4350, gynecare interceed, the design of printing foil of the suspected product seems to be the same, however, the picture is blurry.No conclusion could be reached as on what caused the reported complaint since device was not returned for analysis.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that suspected product was noted on (b)(6) 2020 and was received from an unknown supplier.After comparison with authorized goods, differences were identified on the label printing, label position, barcode and primary wrap.A blue note stick was also found on the individual piece as well.There was no patient involvement.

• Brand Name: GYNECARE INTERCEED 3INX4IN
• Common Device Name: BARRIER, ABSORBABLE, ADHESION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10878112
• Report Number: 2210968-2020-09169
• Device Sequence Number: 4329555
• Product Code: MCN
• UDI-Device Identifier: 10705031005396
• UDI-Public: 10705031005396
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P880047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/28/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: 4350
• Device Catalogue Number: 4350
• Device Lot Number: QBB2061
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 11/20/2020
• Patient Sequence Number: 1