STAPLES NOT SURE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-26 for STAPLES NOT SURE manufactured by Unk.

MAUDE Entry Details

• Report Number: MW5089318
• MDR Report Key: 8931795
• Date Received: 2019-08-26
• Date of Report: 2019-08-21
• Date of Event: 2016-05-26
• Date Added to Maude: 2019-08-26
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: STAPLES
• Generic Name: STAPLE, IMPLANTABLE
• Product Code: GDW
• Date Received: 2019-08-26
• Model Number: NOT SURE
• Catalog Number: NOT SURE
• Lot Number: NOT SURE
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: UNK
• Manufacturer Address: UNK UNK

Device Sequence Number: 2

• Brand Name: FILSHIE CLIP
• Generic Name: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Product Code: KNH
• Date Received: 2019-08-26
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: FEMCARE LTD.

Device Sequence Number: 3

• Brand Name: FILSHIE CLIP
• Generic Name: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Product Code: KNH
• Date Received: 2019-08-26
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: FEMCARE LTD.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Deathisabilit	2019-08-26