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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN CAREGUARD TOOL-LESS TRANSFER BENCH 2/CARTON 9153645723; ADAPTOR, HYGIENE

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UNKNOWN CAREGUARD TOOL-LESS TRANSFER BENCH 2/CARTON 9153645723; ADAPTOR, HYGIENE Back to Search Results
Model Number 98071
Device Problems Break (1069); Device Damaged Prior to Use (2284)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
It has been reported by a dealer that the seat on a (b)(4) transfer bench arrived damaged.
 
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Brand Name
CAREGUARD TOOL-LESS TRANSFER BENCH 2/CARTON 9153645723
Type of Device
ADAPTOR, HYGIENE
Manufacturer (Section D)
UNKNOWN
OH
MDR Report Key4341367
MDR Text Key5215282
Report Number1531186-2014-06464
Device Sequence Number1
Product Code ILS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Source Type Invalid Data
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 12/16/2014,11/04/2014
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 Lay User/Patient
Device Model Number98071
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/16/2014
Distributor Facility Aware Date11/04/2014
Date Report to Manufacturer12/16/2014
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/18/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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