MAUDE Adverse Event Report: ETHICON INC. MALLA PROLENE SMALL 6CM X 11CM; MESH, SURGICAL, POLYMERIC

Catalog Number PMS3

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 01/18/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Attempts have been made to obtain the following information.If further details are received at a later date a supplemental medwatch will be sent.Please clarify if there were any adverse patient consequences due to this event? if yes, please explain in detail.How was procedure successfully completed? please provide the return status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.A picture was received to ethicon inc for evaluation.As per the visual inspection of the picture received, an overwrap packet of the product was observed.The mark of the seal area was observed in the packet and it was not possible determine if the packet was opened in picture.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.No conclusion could be reached as to what caused the reported complaint since the sample was not returned for analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

Event Description

It was reported that a patient underwent a hernia repair on (b)(6) 2022 and the mesh was used.It was reported that in one piece, the seal of packaging was opened before using.It was reported that the surgery was delayed five minutes as a result.There were no adverse patient consequences reported.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 03/02/2022.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, 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.Additional information was requested and the following was obtained: 1.Please clarify if there were any adverse patient consequences due to this event? if yes, please explain in detail: the primary packaging was open leading to the risk that the product inside is not completely sterile.This would be affected to the patient (the risk of infection), as well as the quality of the surgery, safety for patient.2.How was procedure successfully completed? another new piece was replaced for the issued piece.3.Please provide the return status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.01 piece.The complaint product was collected by hap (distributor) from hospital (located in (b)(6)); then will be sent to (b)(4) asap.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 03/25/2022.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, 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.H3 evaluation: one top overwrap and an empty opened folder for product were returned for analysis.The top overwrap was examined for visual inspection to determine any damage related to complaint and no defects were detected, the seal areas were observed continues and no wrinkles or damaged could be noted.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.No conclusion could be reached as to what caused the reported complaint.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• Brand Name: MALLA PROLENE SMALL 6CM X 11CM
• 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 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13549746
• MDR Text Key: 286955293
• Report Number: 2210968-2022-01148
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PMS3
• Device Lot Number: QBBKES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1