GRIPCERT NC23640 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-08-26 for GRIPCERT NC23640 * manufactured by North Coast Medical, Inc..

Event Text Entries

[2171880] While patient was using a reacher device dispensed by physical therapy department he lacerated the outer aspect of his right lower leg about mid calf (appox 5 inches long). The patient was using the device appropriately (to pull on his pants). The reacher has a clip on it so that it may be attached to a walker or wheelchair. This clip is made of hard plastic and the ends are tapered and with an edge. The edge of the clip caused the laceration. The pt was on coumadin and a large amount of bleeding occurred. A pressure dressing was applied and subsequently steri strips were applied. It was noted that the pt's skin was very thin.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2235405
• MDR Report Key: 2235405
• Date Received: 2011-08-26
• Date of Report: 2011-08-26
• Date of Event: 2011-08-02
• Report Date: 2011-08-26
• Date Reported to FDA: 2011-08-26
• Date Added to Maude: 2011-09-06
• Event Key: 0
• Report Source Code: User Facility 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: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: GRIPCERT
• Generic Name: GRIPCERT HELPING HAND
• Product Code: ILD
• Date Received: 2011-08-26
• Model Number: NC23640
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PATIENT
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: NORTH COAST MEDICAL, INC.
• Manufacturer Address: 8100 CAMINO ARROYO GILROY CA 95020 US 95020

Patients

Patient Number	Treatment	Outcome	Date
1	0		2011-08-26