CAPIO 833-114

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-06-10 for CAPIO 833-114 manufactured by Teleflex Medical.

Event Text Entries

[3581165] Doctor was suturing and the tip broke off. What was the original intended procedure? A&p repair. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3208730
• MDR Report Key: 3208730
• Date Received: 2013-06-10
• Date of Report: 2013-06-10
• Date of Event: 2013-04-26
• Report Date: 2013-06-10
• Date Reported to FDA: 2013-06-10
• Date Reported to Mfgr: 2013-07-08
• Date Added to Maude: 2013-07-08
• 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: CAPIO
• Generic Name: NEEDLE WITH SUTURE
• Product Code: MFJ
• Date Received: 2013-06-10
• Model Number: 833-114
• Catalog Number: 833-114
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Age: DA
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: TELEFLEX MEDICAL
• Manufacturer Address: PO BOX 12600 DURHAM NC 27709 US 27709

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-06-10