MAUDE Adverse Event Report: ETHICON INC. MALLA PROLENE 15CM X 15CM; MESH, SURGICAL, POLYMERIC

Catalog Number PMM1

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 09/22/2022

Event Type  malfunction  

Event Description

It was reported that a mesh sample was collected during a field visit as there was doubt about the genuinity of the product available in chemist shops around the hospital.There was no patient involvement.Additional information was requested.

Manufacturer Narrative

(b)(4).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.Analysis summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned samples.Visual analysis of the returned samples revealed that one unopened sample that pertained to product code: (b)(4) was received.The sample was visually inspected and compared with the graphics within the internal system, product code (b)(4) and lot: v2002.Upon visual inspection, multiple discrepancies were identified on the labeling, for example missing barcode, incorrect artwork version, incorrect manufacturing, and expiration dates.In addition, the product artwork writing style and font type did not match the information on file.Based on the samples received, the product is confirmed to be counterfeit due to the discrepancies found in the labeling and packaging material.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.Counterfeit product hence dhr not performed.

• Brand Name: MALLA PROLENE 15CM X 15CM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16265170
• MDR Text Key: 308492036
• Report Number: 2210968-2023-00595
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: BG
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: PMM1
• Device Lot Number: V2002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2022
• Date Manufacturer Received: 01/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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