CONVEEN CONTOUR LEG BAG 5170

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-10-07 for CONVEEN CONTOUR LEG BAG 5170 manufactured by Coloplast Corporation.

Event Text Entries

[5161356] On (b)(6) 2014, reporter received an email from account management at coloplast corporation with a letter of notification for the corrective and removal action for the conveen contour leg bag. Effective (b)(6) 2014, coloplast is performing a corrective and removal action on the following product numbers and lot numbers due to potential leakage from the bag seam when filled. Reporter cannot identify evidence confirming that the fda is aware. Product number 5170. Lot numbers: 3880261, 3932929, 3940329, 3949825, 3968997, 3997778, 4019572, 4047072, 4056422, 4073930, 4092991. Product number 5171. Lot numbers: 3997492, 4006822, 405623, 4100228. Product number 5174. Lot numbers: 3880268, 3932933, 3940332, 3949828, 3969002, 3997782, 40195721, 4047075, 4056428, 4073934, 4092990. (b)(4). Frequency: prn/as needed, route: urinary tract. Diagnosis or reason for use: urinary incontinence.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5038583
• MDR Report Key: 4174363
• Date Received: 2014-10-07
• Date of Report: 2014-10-07
• Date of Event: 2014-09-30
• Date Added to Maude: 2014-10-17
• 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: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: CONVEEN CONTOUR LEG BAG
• Generic Name: URINARY DRAINAGE BAG, LEG
• Product Code: FAQ
• Date Received: 2014-10-07
• Catalog Number: 5170
• Lot Number: 3880261
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COLOPLAST CORPORATION
• Manufacturer Address: MINNEAPOLIS 55411 55411

Device Sequence Number: 2

• Brand Name: CONVEEN CONTOUR LEG BAG
• Generic Name: URINARY DRAINAGE BAG, LEG
• Product Code: FAQ
• Date Received: 2014-10-07
• Catalog Number: 5170
• Lot Number: 3932929
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: COLOPLAST CORPORATION
• Manufacturer Address: MINNEAPOLIS 55411 55411

Device Sequence Number: 3

• Brand Name: CONVEEN CONTOUR LEG BAG
• Generic Name: URINARY DRAINAGE BAG, LEG
• Product Code: FAQ
• Date Received: 2014-10-07
• Catalog Number: 5170
• Lot Number: 3940329
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: COLOPLAST CORPORATION
• Manufacturer Address: MINNEAPOLIS 55411 55411

Device Sequence Number: 4

• Brand Name: CONVEEN CONTOUR LEG BAG
• Generic Name: URINARY DRAINAGE BAG, LEG
• Product Code: FAQ
• Date Received: 2014-10-07
• Catalog Number: 5170
• Lot Number: 3949825
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: COLOPLAST CORPORATION
• Manufacturer Address: MINNEAPOLIS 55411 55411

Device Sequence Number: 5

• Brand Name: CONVEEN CONTOUR LEG BAG
• Generic Name: URINARY DRAINAGE BAG, LEG
• Product Code: FAQ
• Date Received: 2014-10-07
• Catalog Number: 5170
• Lot Number: 3968997
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Sequence No: 5
• Device Event Key: 0
• Manufacturer: COLOPLAST CORPORATION
• Manufacturer Address: MINNEAPOLIS 55411 55411

Device Sequence Number: 6

• Brand Name: CONVEEN CONTOUR LEG BAG
• Generic Name: URINARY DRAINAGE BAG, LEG
• Product Code: FAQ
• Date Received: 2014-10-07
• Catalog Number: 5170
• Lot Number: 3997778
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Sequence No: 6
• Device Event Key: 0
• Manufacturer: COLOPLAST CORPORATION
• Manufacturer Address: MINNEAPOLIS 55411 55411

Device Sequence Number: 7

• Brand Name: CONVEEN CONTOUR LEG BAG
• Generic Name: URINARY DRAINAGE BAG, LEG
• Product Code: FAQ
• Date Received: 2014-10-07
• Catalog Number: 5170
• Lot Number: 4019572
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Sequence No: 7
• Device Event Key: 0
• Manufacturer: COLOPLAST CORPORATION
• Manufacturer Address: MINNEAPOLIS 55411 55411

Device Sequence Number: 8

• Brand Name: CONVEEN CONTOUR LEG BAG
• Generic Name: URINARY DRAINAGE BAG, LEG
• Product Code: FAQ
• Date Received: 2014-10-07
• Catalog Number: 5170
• Lot Number: 4047072
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Sequence No: 8
• Device Event Key: 0
• Manufacturer: COLOPLAST CORPORATION
• Manufacturer Address: MINNEAPOLIS 55411 55411

Device Sequence Number: 9

• Brand Name: CONVEEN CONTOUR LEG BAG
• Generic Name: URINARY DRAINAGE BAG, LEG
• Product Code: FAQ
• Date Received: 2014-10-07
• Catalog Number: 5170
• Lot Number: 4056422
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Sequence No: 9
• Device Event Key: 0
• Manufacturer: COLOPLAST CORPORATION
• Manufacturer Address: MINNEAPOLIS 55411 55411

Device Sequence Number: 10

• Brand Name: CONVEEN CONTOUR LEG BAG
• Generic Name: URINARY DRAINAGE BAG, LEG
• Product Code: FAQ
• Date Received: 2014-10-07
• Catalog Number: 5170
• Lot Number: 4073930
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Sequence No: 10
• Device Event Key: 0
• Manufacturer: COLOPLAST CORPORATION
• Manufacturer Address: MINNEAPOLIS 55411 55411

Device Sequence Number: 11

• Brand Name: CONVEEN CONTOUR LEG BAG
• Generic Name: URINARY DRAINAGE BAG, LEG
• Product Code: FAQ
• Date Received: 2014-10-07
• Catalog Number: 5170
• Lot Number: 4092991
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Sequence No: 11
• Device Event Key: 0
• Manufacturer: COLOPLAST CORPORATION
• Manufacturer Address: MINNEAPOLIS 55411 55411

Device Sequence Number: 12

• Brand Name: CONVEEN CONTOUR LEG BAG
• Generic Name: URINARY DRAINAGE BAG, LEG
• Product Code: FAQ
• Date Received: 2014-10-07
• Catalog Number: 5171
• Lot Number: 3997492
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Sequence No: 12
• Device Event Key: 0
• Manufacturer: COLOPLAST CORPORATION
• Manufacturer Address: MINNEAPOLIS 55411 55411

Device Sequence Number: 13

• Brand Name: CONVEEN CONTOUR LEG BAG
• Generic Name: URINARY DRAINAGE BAG, LEG
• Product Code: FAQ
• Date Received: 2014-10-07
• Catalog Number: 5171
• Lot Number: 4006822
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Sequence No: 13
• Device Event Key: 0
• Manufacturer: COLOPLAST CORPORATION
• Manufacturer Address: MINNEAPOLIS 55411 55411

Device Sequence Number: 14

• Brand Name: CONVEEN CONTOUR LEG BAG
• Generic Name: URINARY DRAINAGE BAG, LEG
• Product Code: FAQ
• Date Received: 2014-10-07
• Catalog Number: 5171
• Lot Number: 405623
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Sequence No: 14
• Device Event Key: 0
• Manufacturer: COLOPLAST CORPORATION
• Manufacturer Address: MINNEAPOLIS 55411 55411

Device Sequence Number: 15

• Brand Name: CONVEEN CONTOUR LEG BAG
• Generic Name: URINARY DRAINAGE BAG, LEG
• Product Code: FAQ
• Date Received: 2014-10-07
• Catalog Number: 5171
• Lot Number: 4100228
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Sequence No: 15
• Device Event Key: 0
• Manufacturer: COLOPLAST CORPORATION
• Manufacturer Address: MINNEAPOLIS 55411 55411

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-10-07