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

Model Number	521187-31B
Medical Device Problem Codes	Stretched (1601); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	08/02/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
(b)(4).Inner coil got loosened within patient; had to be surgically removed.
Additional Manufacturer Narrative
Based on risk assessment and clinical evaluation report this case is considered as closed.
Event or Problem Description
Irn# (b)(4).Inner coil got loosened within patient; had to be surgically removed.

• Brand Name: SONOLONG SONO
• Common Device Name: 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
• Report Number: 9611612-2018-00032
• Device Sequence Number: 1985784
• Product Code: CAZ
• UDI-Device Identifier: 14048223020699
• UDI-Public: 14048223020699
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K113188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2018

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?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 08/06/2018
• Supplement Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 08/23/2018
• Supplement Report FDA Received Date: 10/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other