PWRD ECH FLEX 45MM 34CM SHAFT PSE45A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-31 for PWRD ECH FLEX 45MM 34CM SHAFT PSE45A manufactured by Ethicon Endo-surgery, Llc..

MAUDE Entry Details

• Report Number: 3005075853-2020-01891
• MDR Report Key: 9908485
• Report Source: FOREIGN,HEALTH PROFESSIONAL
• Date Received: 2020-03-31
• Date of Report: 2020-03-09
• Date of Event: 2020-03-05
• Date Mfgr Received: 2020-03-09
• Device Manufacturer Date: 2019-11-01
• Date Added to Maude: 2020-03-31
• 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: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS. KARA DITTY-BOVARD
• Manufacturer Street: 475 CALLE C
• Manufacturer City: GUAYNABO 00969
• Manufacturer Country: *
• Manufacturer Postal: 00969
• Manufacturer Phone: 6107428552
• Manufacturer G1: ETHICON ENDO-SURGERY, LLC.
• Manufacturer Street: 475 CALLE C
• Manufacturer City: GUAYNABO 00969
• Manufacturer Country: *
• Manufacturer Postal Code: 00969
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PWRD ECH FLEX 45MM 34CM SHAFT
• Generic Name: STAPLE, IMPLANTABLE
• Product Code: GDW
• Date Received: 2020-03-31
• Returned To Mfg: 2020-03-26
• Model Number: PSE45A
• Catalog Number: PSE45A
• Lot Number: T95333
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ETHICON ENDO-SURGERY, LLC.
• Manufacturer Address: 475 CALLE C GUAYNABO 00969 * 00969

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-03-31