MAUDE Adverse Event Report: COLOPLAST A/S DRM 4 HL WIRE W/O FILIF 90; DORMIA STONE DISLODGER

Model Number DOR4241002

Device Problems Migration or Expulsion of Device (1395); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2015

Event Type  malfunction  

Event Description

According to the complaint received, after manipulation, the basket pulled off and remained in the ureter.Resulted in loss of time - no clinical consequences for patient.3 dormia were used during the procedure.

Manufacturer Narrative

Should additional information be received, a follow-up report will be filed.

• Brand Name: DRM 4 HL WIRE W/O FILIF 90
• Type of Device: DORMIA STONE DISLODGER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S MANUFACTURING FRANCE SAS; 9 avenue edmond rostand; sarlat-la-canéda, 2420 6; FR 24206
• Manufacturer Contact: megan daniel ; 1601 w river rd n; minneapolis, MN 55411 ; 6123024930
• MDR Report Key: 4628633
• MDR Text Key: 5660597
• Report Number: 9610711-2015-00009
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K900269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: DOR4241002
• Device Catalogue Number: DOR4241002
• Device Lot Number: 4269245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2015
• Initial Date FDA Received: 03/24/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/26/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention