FULL BODY W/COMMODE MESH LRG. 9153632098 R115

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2015-06-10 for FULL BODY W/COMMODE MESH LRG. 9153632098 R115 manufactured by Unknown.

Event Text Entries

[20778103] Original order (b)(4) for slings r115 four slings are fraying and ripping at the seams for the straps lynne schramm (b)(4). No additional information provided.
Patient Sequence No: 1, Text Type: D, B5


[21077953] A returned was issued and the product was evaluated upon receipt. A follow up will be filed if/when any additional information is provided.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1525712-2015-03383
MDR Report Key4835867
Report Source08
Date Received2015-06-10
Date of Report2015-05-13
Date Mfgr Received2015-05-13
Date Added to Maude2015-07-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationMEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactKEVIN GUYTON
Manufacturer StreetONE INVACARE WAY
Manufacturer CityELYRIA OH 44035
Manufacturer CountryUS
Manufacturer Postal44035
Manufacturer Phone8003336900
Manufacturer G1UNKNOWN
Manufacturer CityOH
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFULL BODY W/COMMODE MESH LRG. 9153632098
Generic NameSLING, OVERHEAD SUSPENSION, WHEELCHAIR
Product CodeINE
Date Received2015-06-10
Returned To Mfg2015-06-04
Model NumberR115
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerUNKNOWN
Manufacturer AddressOH US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2015-06-10

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