MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO HERNIA PLUG UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

Device Problem Device Markings/Labelling Problem (2911)

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

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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, 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.(b)(4).The following information was requested, but unavailable: please provide lot number? are there pictures of the damaged device available? no device will be returning for this case.If further details are received at a later date a supplemental medwatch will be sent.Event associated with ultrapro hernia system reported via mw# 2210968-2022-06812.Event associated with ultrapro plug reported.

Event Description

It was reported that a patient underwent an unknown procedure on an unknown date and the mesh was used.It was reported that the size of the product is not written on the package so the surgeon is confused.It was reported that another device was used to complete the case.There were no adverse consequences to the patient.Additional information was requested.

• Brand Name: ULTRAPRO HERNIA PLUG UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; p.o. box 1409; norderstedt 22841 ; GM 22841
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15271324
• MDR Text Key: 305177531
• Report Number: 2210968-2022-06813
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K070224
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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