MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SONOLONG SONO; CONTINUOUS PERIPHERAL ANAESTHESIA, KIT, ECHOGENIC, STIMULATION (DUAL GUIDANCE)

Model Number 521187-31B

Device Problems Stretched (1601); Improper or Incorrect Procedure or Method (2017)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 08/02/2018

Event Type  malfunction  

Manufacturer Narrative

Event took place in austria and has been reported through german distribution subsidiary pajunk medical produkte (b)(4).Currently the data is poor and the device has not been returned/ analysed.As soon as further data will be available a follow up report will be sent in to the agency.

Event Description

(b)(4).Inner coil got loosened within patient; had to be surgically removed.

Manufacturer Narrative

Based on risk assessment and clinical evaluation report this case is considered as closed.

Event Description

Irn# (b)(4).Inner coil got loosened within patient; had to be surgically removed.

• Brand Name: SONOLONG SONO
• Type of Device: CONTINUOUS PERIPHERAL ANAESTHESIA, KIT, ECHOGENIC, STIMULATION (DUAL GUIDANCE)
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 7808037
• MDR Text Key: 117961115
• Report Number: 9611612-2018-00032
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 14048223020699
• UDI-Public: 14048223020699
• Combination Product (y/n): N
• PMA/PMN Number: K113188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Type of Report: Initial,Followup
• Report Date: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2022
• Device Model Number: 521187-31B
• Device Catalogue Number: 521187-31B
• Device Lot Number: 1216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Date Manufacturer Received: 08/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other