• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 STATLOCK SL FOLEY, UNKNOWN CODE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

C.R. BARD, INC. (COVINGTON) -1018233 STATLOCK SL FOLEY, UNKNOWN CODE Back to Search Results
Catalog Number UNKNOWN
Device Problem Disconnection (1171)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device was not returned.
 
Event Description
It was reported that the statlock clip disconnected from the adhesive pad.
 
Event Description
It was reported that the statlock clip disconnected from the adhesive pad.
 
Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, a device history record could not be reviewed.Although the product family is unknown, the foley statlock product ifus are found to be adequate based on past reviews.Section a through f - the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
STATLOCK SL FOLEY, UNKNOWN CODE
Type of Device
STATLOCK
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key7754438
MDR Text Key116463989
Report Number1018233-2018-03407
Device Sequence Number0
Product Code EYJ
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor,other
Type of Report Initial,Followup
Report Date 09/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/17/2018
Initial Date FDA Received08/06/2018
Supplement Dates Manufacturer Received08/20/2018
Supplement Dates FDA Received09/10/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-