MULTIPLE CLIP APPLIER LIGACLIP ETHMCM30

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-06-21 for MULTIPLE CLIP APPLIER LIGACLIP ETHMCM30 manufactured by Sterilmed, Inc..

MAUDE Entry Details

• Report Number: 2134070-2019-00137
• MDR Report Key: 8723058
• Report Source: HEALTH PROFESSIONAL,USER FACI
• Date Received: 2019-06-21
• Date of Report: 2019-05-31
• Date of Event: 2019-05-14
• Date Mfgr Received: 2019-07-24
• Device Manufacturer Date: 2018-10-08
• Date Added to Maude: 2019-06-21
• 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
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. GABRIEL ALFAGEME
• Manufacturer Street: 31 TECHNOLOGY DR
• Manufacturer City: IRVINE CA 92618
• Manufacturer Country: US
• Manufacturer Postal: 92618
• Manufacturer Phone: 9497898687
• Manufacturer G1: STERILMED, INC.
• Manufacturer Street: 5010 CHESHIRE PARKWAY STE 2
• Manufacturer City: PLYMOUTH MN 55446
• Manufacturer Country: US
• Manufacturer Postal Code: 55446
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MULTIPLE CLIP APPLIER LIGACLIP
• Generic Name: CLIP, IMPLANTABLE, REPROCESSED
• Product Code: NMJ
• Date Received: 2019-06-21
• Returned To Mfg: 2019-07-24
• Catalog Number: ETHMCM30
• Lot Number: 2058827
• Device Expiration Date: 2019-10-08
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: STERILMED, INC.
• Manufacturer Address: 5010 CHESHIRE PARKWAY STE 2 PLYMOUTH MN 55446 US 55446

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-06-21