MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG LEVEL ONE NEURO; MESH

Model Number 25-010-20-09

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 03/20/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that mesh was removed due to the patient's pain after a suspected fall.

Manufacturer Narrative

An investigation was performed on the basis of complaint statistics as no device was returned for evaluation.The complaint percentage falls within the design risk limits adhered to at klm.The review of the device history records was not possible due to no lot number being identified.Due to no device being returned the root cause for the failure cannot be determined.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.

• Brand Name: LEVEL ONE NEURO
• Type of Device: MESH
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• Manufacturer (Section G): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• Manufacturer Contact: jennifer damato ; p.o. box 16369; jacksonville, FL 32245 ; 9046417746
• MDR Report Key: 7397394
• MDR Text Key: 104382049
• Report Number: 9610905-2018-00040
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00888118035776
• UDI-Public: (01)00888118035776
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944565
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 25-010-20-09
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/20/2018
• Date Manufacturer Received: 06/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR