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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL SURGICAL INNOVATIONS SL FOLEY SWIVEL SILICONE TRICOT
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DAVOL SURGICAL INNOVATIONS SL FOLEY SWIVEL SILICONE TRICOT Back to Search Results
Catalog Number FOL0102
Device Problem Material Twisted/Bent (2981)
Patient Problem Urinary Retention (2119)
Event Date 02/21/2014
Event Type  malfunction  
Event Description
It was reported that the statlock spun and kinked off the catheter, causing urine retention in the patient.
 
Manufacturer Narrative
The sample was not returned.The lot number is unknown; therefore, the device history record could not be reviewed.(b)(4).
 
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Brand Name
SL FOLEY SWIVEL SILICONE TRICOT
Manufacturer (Section D)
DAVOL SURGICAL INNOVATIONS
cd. juarez, chih s.a. de c.v.
MX 
Manufacturer (Section G)
DAVOL SURGICAL INNOVATIONS
ave. roberto fierro #6408
parque industrial aeropuerto
cd. juarez, chih s.a. de c.v. 3269 0
MX   32690
Manufacturer Contact
beverly schaner
8195 industrial blvd.
covington, GA 30014
7707846100
MDR Report Key3881648
MDR Text Key20781139
Report Number1018233-2014-00074
Device Sequence Number1
Product Code EYJ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 03/13/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberFOL0102
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Date Manufacturer Received03/13/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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