GEL-E DONUT - SMALL 92025-B

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-05-13 for GEL-E DONUT - SMALL 92025-B manufactured by Philips Respironics - Chmv.

Event Text Entries

[15106834] Children's medical ventures (chmv) received a report of a product issue associated with the small gel-e donut positioning devices. The complaint allegation reports an issue of mold associated with five cases of the product. There is no allegation of any affected products being put into patient use and no allegation of patient harm has been reported. The complaint issue alleged by the customer was not able to be confirmed because the product has not been received by the manufacturer for evaluation. No unique product identifiers such as lot numbers or expiration dates have been reported.
Patient Sequence No: 1, Text Type: D, B5


[15288752] (b)(4). The gel products are intended to provide support for infants in a hospital environment and a caregiver is to be present during use. Normal use will conform to accepted medical practice and to the labeling instructions. The gel products instructions for use state that before use, remove the outer plastic bag and wipe all surfaces with an antibacterial agent. The instructions for use further state to cover with a disposable cover or soft cloth before patient use. Chmv has determined that due to an increased amount of customer complaints associated with the reported issue, a formal investigation has been initiated. Once the investigation has been concluded, a follow-up information report will be filed detailing the findings.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3007056120-2014-00015
MDR Report Key3912184
Report Source99
Date Received2014-05-13
Date of Report2014-04-14
Date Mfgr Received2014-04-14
Date Added to Maude2014-07-15
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactRUSTY KELLY
Manufacturer Street12151 RESEARCH PKWY SUITE 200
Manufacturer CityORLANDO FL 32826
Manufacturer CountryUS
Manufacturer Postal32826
Manufacturer Phone4074556166
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGEL-E DONUT - SMALL
Product CodeFMP
Date Received2014-05-13
Model Number92025-B
Lot NumberNOT GIVEN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerPHILIPS RESPIRONICS - CHMV
Manufacturer Address191 WYNGATE DR MONROEVILLE PA 15146 US 15146


Patients

Patient NumberTreatmentOutcomeDate
10 2014-05-13

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