PREC BRONCH ALL 1.8 115 100507

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-07-31 for PREC BRONCH ALL 1.8 115 100507 manufactured by Micro-tech (nanjing) Co., Ltd..

MAUDE Entry Details

• Report Number: 1320894-2019-00277
• MDR Report Key: 8846239
• Report Source: FOREIGN,HEALTH PROFESSIONAL,U
• Date Received: 2019-07-31
• Date of Report: 2019-09-09
• Date of Event: 2019-06-06
• Date Mfgr Received: 2019-08-23
• Device Manufacturer Date: 2019-01-05
• Date Added to Maude: 2019-07-31
• 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: PHARMACIST
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. JOHN BERGA
• Manufacturer Street: 11311 CONCEPT BLVD.
• Manufacturer City: LARGO FL 33773
• Manufacturer Country: US
• Manufacturer Postal: 33773
• Manufacturer Phone: 7273995358
• Manufacturer G1: MICRO-TECH (NANJING) CO., LTD.
• Manufacturer Street: NO. 10 GAOKE THIRD ROAD
• Manufacturer City: NANJING, 210032
• Manufacturer Country: CH
• Manufacturer Postal Code: 210032
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PREC BRONCH ALL 1.8 115
• Generic Name: FORCEPS, BIOPSY, NON-ELECTRIC
• Product Code: FCL
• Date Received: 2019-07-31
• Returned To Mfg: 2019-08-19
• Catalog Number: 100507
• Lot Number: M181215002
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MICRO-TECH (NANJING) CO., LTD.
• Manufacturer Address: NO. 10 GAOKE THIRD ROAD NANJING, 210032 CH 210032

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-07-31