MAUDE Adverse Event Report: INTECH FINAL TIGHTENER PERLA TL

Model Number TLF-IN 05 41-N

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Unspecified Infection (1930)

Event Date 03/20/2024

Event Type  Injury  

Manufacturer Narrative

We are waiting for the return of the instrument to investigate.

Event Description

On 21.Mar.2024, we received a complaint from spain, registered under (b)(4) reporting that during a surgery on (b)(6) 2024, when using the final tightener instrument reference tlf-in 05 41-n, batch number 6-9649/051, brown water leaked into the surgical site.High risk of infection reported.The event is reported to fda because this instrument is used in the us market.

• Brand Name: FINAL TIGHTENER PERLA TL
• Type of Device: FINAL TIGHTENER PERLA TL
• Manufacturer (Section D): INTECH
• Manufacturer Contact: laure-allison verboux ; chemin du pré fleuri 3; plan-les-ouates, geneva 1228 ; SZ 1228
• MDR Report Key: 18986110
• MDR Text Key: 338700773
• Report Number: 3007728266-2024-00003
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 07640450868954
• UDI-Public: 07640450868954
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TLF-IN 05 41-N
• Device Catalogue Number: TLF-IN 05 41-N
• Device Lot Number: 6-9649
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other