MAUDE Adverse Event Report: ETHICON INC. SURGICEL* 5X7.5CM; AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Catalog Number 1903GB

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information was requested, and the following was obtained: how was the product purchased? (b)(4) turkish liras for each is there an indication of how the product was distributed? no.Is there any indication of the source? no.Based on the packaging, is there any indication of which market the original genuine product may have come from? lots do not belong to any jnj product.Was the device used on a patient? if so, was there any patient consequence? yes but there is no patient consequence.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.One pouch with tyvek and orc of product code 1903gb and lot number 3931247 was received for evaluation.The product was decontaminated and well packaged.The device received was not in its original packaging and there was only one pouch, not the full box.The product was manipulated as it was a bit folded but there was no damage such as tears or holes on it.Many discrepancies were found during the investigation specifically regarding the packaging and surgicel product itself.Therefore, based on the product evaluation, the complaint is confirmed.No nonconformance will be opened if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that one of the companies dealers saw that there was a product, absorbable hemostat, from a different source in a hospital.No adverse patient consequences were reported.Additional information was requested.

• Type of Device: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; rue du puits godet 20; neuchatel CH-20 00; SZ CH-2000
• Manufacturer Contact: elbita bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 11064275
• MDR Text Key: 223444187
• Report Number: 2210968-2020-10233
• Device Sequence Number: 1
• Product Code: LMG
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: N12159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/21/2020

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 Expiration Date: 10/31/2022
• Device Catalogue Number: 1903GB
• Device Lot Number: 3931247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2020
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 12/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1