SPROTTE 2.G 121251-27A 001151-683

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-01-20 for SPROTTE 2.G 121251-27A 001151-683 manufactured by Pajunk Gmbh Medizintechnologie.

MAUDE Entry Details

• Report Number: 9611612-2020-00002
• MDR Report Key: 9605110
• Report Source: DISTRIBUTOR
• Date Received: 2020-01-20
• Date of Report: 2020-02-18
• Date of Event: 2020-01-07
• Date Mfgr Received: 2020-01-10
• Date Added to Maude: 2020-01-20
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR CHRISTIAN QUASS
• Manufacturer Street: KARL-HALL-STR. 1 TUTTLINGER STR. 7
• Manufacturer City: GEISINGEN, 78187
• Manufacturer Country: GM
• Manufacturer Postal: 78187
• Manufacturer G1: PAJUNK GMBH MEDIZINTECHNOLOGIE
• Manufacturer Street: KARL-HALL-STR. 1 TUTTLINGER STR. 7
• Manufacturer City: GEISINGEN, 78187
• Manufacturer Country: GM
• Manufacturer Postal Code: 78187
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SPROTTE 2.G
• Generic Name: SPINAL NEEDLE, SINGLE USE
• Product Code: BSP
• Date Received: 2020-01-20
• Returned To Mfg: 2020-01-16
• Model Number: 121251-27A
• Catalog Number: 001151-683
• Lot Number: UNKNOWN
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PAJUNK GMBH MEDIZINTECHNOLOGIE
• Manufacturer Address: KARL-HALL-STR. 1 TUTTLINGER STR. 7 GEISINGEN, 78187 GM 78187

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention	2020-01-20