6833 UMBILICAL CORD CLAMP, 100/CS 07

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2000-05-31 for 6833 UMBILICAL CORD CLAMP, 100/CS 07 manufactured by Deroyal Surgical.

Event Text Entries

[15740470] User facility reported incident of newborn blood loss following umbilical cord clamping procedure. User facility reported no injury to pt.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1046367-2000-00022
• MDR Report Key: 280821
• Report Source: 07
• Date Received: 2000-05-31
• Date of Report: 2000-05-31
• Date of Event: 2000-05-02
• Date Facility Aware: 2000-05-02
• Report Date: 2000-05-31
• Date Reported to FDA: 2000-05-31
• Date Mfgr Received: 2000-05-02
• Date Added to Maude: 2000-06-08
• 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: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Street: 200 DEBUSK LN
• Manufacturer City: POWELL TN 37849
• Manufacturer Country: US
• Manufacturer Postal: 37849
• Manufacturer Phone: 8659387828
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: 6833 UMBILICAL CORD CLAMP, 100/CS
• Generic Name: 7N8 UMBILICAL CORD CLAMP
• Product Code: HFW
• Date Received: 2000-05-31
• Model Number: 07
• Catalog Number: 6833
• Lot Number: UNK
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 271776
• Manufacturer: DEROYAL SURGICAL
• Manufacturer Address: 200 DEBUSK LN POWELL TN 37849 US
• Baseline Brand Name: UMBILICAL CORD CLAMP, 100/CS
• Baseline Generic Name: 7N8 UMBILICAL CORD CLAMP
• Baseline Model No: 07
• Baseline Catalog No: 6833
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2000-05-31