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

Catalog Number PMS3

Device Problem Material Integrity Problem (2978)

Patient Problem Diaphoresis (2452)

Event Date 02/14/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Attempts are being made to obtain the following information. to date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Name of initial surgical procedure? the diagnosis and indication for the initial surgical procedure? what were current symptoms following the index surgical procedure? onset date? it is stated: "the patient was re-used a new device." was the mesh was removed and a new one implanted? if yes, was this change performed during the same surgical procedure? was there any patient consequence or change in the post-operative care of the patient as a result of the event? (extended hospital stay, readmission, re-operation, etc.).What is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status?.

Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2022 and the mesh was implanted.It was reported that there was a device fixation issue.It was reported that the patient had concomitant medication anti-inflammatory drugs to prevent infection.It was reported that the device was fixed on the patient in the surgery.A few hours later, it was found that the device fixation was not firm.The inspection found that the patient was sweating in hot weather, which may lead to the device fixation being unstable.It was also reported that the patient was re-used a new device, and then it was used normally.Additional information was requested.

• 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 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14116530
• MDR Text Key: 293164590
• Report Number: 2210968-2022-02693
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PMS3
• Device Lot Number: PHH082
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male