MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SONOLONG CURL ECHO; ANAESTHESIA CONDUCTION CATHETER, PERIPHERAL, CONTINUOUS ADMINISTRATION

Model Number 581188-31C

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 03/08/2019

Event Type  Injury  

Manufacturer Narrative

Event took place in (b)(6) and has been reported through (b)(4).Currently the data is poor and the device has not been sent back/ analysed.As soon as further data will be available a follow up report will be sent in to the agency.Device is not yet registered with gudid but similar devices of the same series are marketed in the us.

Event Description

Irn# (b)(4).Initial reporters narrative: patient returned in his house with a kt after a ambulatory surgery: one month after remove the kt, the patient returned to hospital because she has pain and she noted a foreign body in her skin.A general anesthesia have been necessary to remove the fragment.

Event Description

Irn# (b)(4).Initial reporters narrative: patient returned in his house with a kt after a ambulatory surgery: one month after remove the kt, the patient returned to hospital because she has pain and she noted a foreign body in her skin.A general anesthesia have been necessary to remove the fragment.

Manufacturer Narrative

Based on risk assessment and clinical evaluation report as well as substantiated by post market data this case is considered as closed.Device is not yet registered with gudid but similar devices of the same series are marketed in the us.Attachment: [2019-04-10_pn1447_final-report_617_092-19.Pdf].

• Brand Name: SONOLONG CURL ECHO
• Type of Device: ANAESTHESIA CONDUCTION CATHETER, PERIPHERAL, CONTINUOUS ADMINISTRATION
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 8454707
• MDR Text Key: 139959914
• Report Number: 9611612-2019-00007
• Device Sequence Number: 1
• Product Code: BSO
• 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
• Type of Report: Initial,Followup
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2023
• Device Model Number: 581188-31C
• Device Catalogue Number: 581188-31C
• Device Lot Number: 1247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Date Manufacturer Received: 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other