MAUDE Adverse Event Report: ETHICON INC. PROLENE SOFT MESH 3INX6IN; MESH, SURGICAL, POLYMERIC

Model Number	SPMII
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).  a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.    additional information was requested and the following was obtained: please provide procedure name.It is stated: "one foil was used and it seems to be unsterile." please explain how the device was defective.I.E did the foil had any hole or tear? any open or incomplete seal? did the mesh had foreign matter such as dust, moisture, blood, etc? please explain in detail.Was the mesh implanted on the patient or not? if yes, was it removed during the same procedure? were there any patient consequences? if yes, please explain in detail? answers: inguinal hernia surgery.One foil was unfolded, it is opened already.Out of six foils in that box, only one foil did not seal properly.They didn't use that mesh.There are no patient consequences.
Event or Problem Description
It was reported that a patient underwent an inguinal hernia repair procedure on an unknown date and the mesh was used.It was reported that prior to the procedure, the foil packaging of the device was unfolded and opened.The foil packaging was not sealed properly so the device appeared to be unsterile.The mesh was not used.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 11/27/2021.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: a piece of the box and one mesh product code was returned for analysis.The foil packet was not received for evaluation.In order to evaluate the conditions of the returned sample, the mesh was observed intact, no damages could be observed.In addition, the mesh was observed to be placed on a plastic paper with irregular cuts in the edges that means that this paper was not part of packaging process.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.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• Brand Name: PROLENE SOFT MESH 3INX6IN
• Common Device Name: 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: 12243066
• Report Number: 2210968-2021-06804
• Device Sequence Number: 17134485
• Product Code: FTL
• UDI-Device Identifier: 10705031050471
• UDI-Public: 10705031050471
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K962530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2021

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: 06/30/2024
• Device Model Number: SPMII
• Device Catalogue Number: SPMII
• Device Lot Number: PHB146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2021
• Supplement Date Received by Manufacturer: 10/31/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 11/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown