WEDGIE - 3"X4"X5" 91014

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-09-24 for WEDGIE - 3"X4"X5" 91014 manufactured by Philips Medical Systems.

Event Text Entries

[5192659] The customer reported mold on the wedgie product. No pt incident/injury was reported.
Patient Sequence No: 1, Text Type: D, B5


[12506304] (b)(4). The customer reported mold on the wedgie product. No pt incident/injury was reported. This complaint is being reported, as no material is available for eval to confirm that there is no mold in/on the product. There is no current evidence that mold will grow inside the wedgie product (gel matrix). There is no evidence of gel "sweating" through the bladder for mold to grow on the outside of the bladder. The bladder is made of vinyl, which is a different material from that used for the gel-e donut product. No product malfunction can be confirmed/determined, as no material is available for eval/testing.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1218950-2014-07330
MDR Report Key4309731
Report Source06
Date Received2014-09-24
Date of Report2014-06-17
Date Mfgr Received2014-06-17
Date Added to Maude2014-12-15
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactNANCY ATAIDE
Manufacturer Street3000 MINUTEMAN RD.
Manufacturer CityANDOVER MA 01810
Manufacturer CountryUS
Manufacturer Postal01810
Manufacturer Phone9786597429
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameWEDGIE - 3"X4"X5"
Product CodeFMP
Date Received2014-09-24
Model Number91014
Lot NumberLOT CODE NOT PROVIDED - NO
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerPHILIPS MEDICAL SYSTEMS
Manufacturer Address3000 MINUTEMAN RD. ANDOVER MA 01810 US 01810


Patients

Patient NumberTreatmentOutcomeDate
10 2014-09-24

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