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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S SILIC FOLEY CATH 5/10ML/5; SILICONE FOLEY CATHETER
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COLOPLAST A/S SILIC FOLEY CATH 5/10ML/5; SILICONE FOLEY CATHETER Back to Search Results
Model Number AA61121002
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Patient Involvement (2645)
Event Date 11/21/2014
Event Type  malfunction  
Event Description
Hair in the packaging, whereas the packaging was still closed.
 
Manufacturer Narrative
One (1) sealed pouched containing a folysil was returned.Upon visual examination, a hair was noted at the distal tip of the catheter on the balloon inside the inner pouch.Based upon the evaluation of the returned products, this complaint can be confirmed as reported.
 
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Brand Name
SILIC FOLEY CATH 5/10ML/5
Type of Device
SILICONE FOLEY CATHETER
Manufacturer (Section D)
COLOPLAST A/S
holtedam-1
humlebaek 3050
DA  3050
Manufacturer (Section G)
COLOPLAST MANUFACTURING FRANCE, SAS
9 avenue edmond rostand
sarlat-la-caneda 2420 6
FR   24206
Manufacturer Contact
megan daniel
1601 w. river road n.
minneapolis, MN 55411
6123024930
MDR Report Key4360847
MDR Text Key17936135
Report Number9610711-2014-00037
Device Sequence Number1
Product Code EZL
Combination Product (y/n)N
PMA/PMN Number
K013174
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Type of Report Initial
Report Date 12/19/2014
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 Date01/20/2019
Device Model NumberAA61121002
Device Catalogue NumberAA61121002
Device Lot Number3933882
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 11/21/2014
Initial Date FDA Received12/21/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/20/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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