HOLLISTER CE 0050 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-08-01 for HOLLISTER CE 0050 * manufactured by Hollister, Inc..

Event Text Entries

[215554] Add'l info rec'd from mfr 11/30/00: the investigation revealed that: there was no injury involved in the reported incident and the device involved was discarded and was not available for further testing or investigation. In addition the investigation revealed that the lot number of the device involved could not be identified. Therefore, lot sample testing could not be performed. As a result of the investigation and the findings discussed above, hollister considers this file to be closed.
Patient Sequence No: 1, Text Type: D, B5

[22185278] Mother of newborn noticed that umbilical clamp was unclamped. Small amount of bleeding noted.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1019523
• MDR Report Key: 289056
• Date Received: 2000-08-01
• Date of Report: 2000-07-31
• Date of Event: 2000-07-22
• Date Added to Maude: 2000-08-11
• 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: 0
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: HOLLISTER
• Generic Name: UMBILICAL CORD CLAMP
• Product Code: HFW
• Date Received: 2000-08-01
• Model Number: CE 0050
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 279730
• Manufacturer: HOLLISTER, INC.
• Manufacturer Address: 2000 HOLLISTER DR. LIBERTYVILLE IL 60048 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2000-08-01