RANEY SCALP CLIPS 20-1037

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 1999-05-12 for RANEY SCALP CLIPS 20-1037 manufactured by Johnson & Johnson Professional, Inc..

Event Text Entries

[157681] Customer reports clips broke during use and portions of the clips had to be removed from the surgical site.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1219655-1999-00094
• MDR Report Key: 222806
• Report Source: 07
• Date Received: 1999-05-12
• Date of Report: 1999-05-12
• Date Mfgr Received: 1999-04-21
• Device Manufacturer Date: 1997-10-01
• Date Added to Maude: 1999-05-14
• 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: 0
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: RANEY SCALP CLIPS
• Generic Name: CLIP, SCALP
• Product Code: HBO
• Date Received: 1999-05-12
• Returned To Mfg: 1999-04-21
• Model Number: NA
• Catalog Number: 20-1037
• Lot Number: KP484
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 216070
• Manufacturer: JOHNSON & JOHNSON PROFESSIONAL, INC.
• Manufacturer Address: 15 COMMERCE WAY NORTON MA 02766 US
• Baseline Brand Name: RANEY SCALP CLIPS
• Baseline Generic Name: CLIPS, SCALP
• Baseline Model No: NA
• Baseline Catalog No: 20-1037
• Baseline ID: NA
• Baseline Device Family: RANEY SCALP CLIPS
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: Y
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1999-05-12