PILLING WECK *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-11-19 for PILLING WECK * manufactured by Pilling Weck Surgical Surgical Division.

Event Text Entries

[154623] On 9/11/98, tip broke off, retrieved. On 10/20/98, tip broke off, not retrieved. Two instruments broke. Instruments were new.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1015001
• MDR Report Key: 198064
• Date Received: 1998-11-19
• Date Added to Maude: 1998-11-23
• 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 Sequence Number: 1

• Brand Name: PILLING WECK
• Generic Name: EAR PROBE
• Product Code: KAK
• Date Received: 1998-11-19
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 192412
• Manufacturer: PILLING WECK SURGICAL SURGICAL DIVISION
• Manufacturer Address: 420 DELEWARE AVE. FORT WASHINGTON PA 19034 US

Device Sequence Number: 2

• Brand Name: PILLING WECK
• Generic Name: EAR PROBE
• Product Code: KAK
• Date Received: 1998-11-19
• Model Number: *
• Catalog Number: 20300
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 2
• Device Event Key: 192413
• Manufacturer: PILLING WECK SURGICAL SURGICAL DIVISION
• Manufacturer Address: 420 DELEWARE AVE. FORT WASHINGTON PA 19034 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		1998-11-19