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 05,06 report with the FDA on 2001-09-24 for RANEY SCALP CLIPS 20-1037 manufactured by Codman & Shurtleff, Inc..

Event Text Entries

[232664] Hosp reports scalp clip may have caused or contributed to delayed healing of incision site.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1226348-2001-00160
• MDR Report Key: 353042
• Report Source: 05,06
• Date Received: 2001-09-24
• Date of Report: 2001-08-29
• Date of Event: 2001-08-24
• Date Mfgr Received: 2001-08-29
• Date Added to Maude: 2001-09-26
• 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
• Manufacturer Contact: MATTHEW KING
• Manufacturer Street: 325 PARAMOUNT DRIVE
• Manufacturer City: RAYNHAM MA 02767
• Manufacturer Country: US
• Manufacturer Postal: 02767
• Manufacturer Phone: *3106
• 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: RANEY SCALP CLIPS
• Generic Name: CLIPS, SCALP
• Product Code: HBO
• Date Received: 2001-09-24
• Model Number: NA
• Catalog Number: 20-1037
• Lot Number: UNK
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 342297
• Manufacturer: CODMAN & SHURTLEFF, INC.
• Manufacturer Address: 325 PARAMOUNT DR. RAYNHAM MA 02767 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	2001-09-24