GEL-E DONUT - MEDIUM 92025-C

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 GEL-E DONUT - MEDIUM 92025-C manufactured by Philips Medical Systems.

Event Text Entries

[5192665] The customer reported that the surgery department discovered 2 small black spots on product. There was no reported pt incident/injury.
Patient Sequence No: 1, Text Type: D, B5


[12506630] (b)(4). Qty (b)(4) surgery department discovered 2 small black spots on product. There was no reported pt incident/ injury. The 92025-c gel-e donut was evaluated. The 92025-c gel-e donut functioned as designed. Replacement 92025-c gel-e donut was ordered and shipped to the customer site. Returned 92025-c gel-e donut will be scraped after the eval has been completed. There was not a product malfunction, found to be performing as designed. No formal response was requested and none is warranted.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1218950-2014-07322
MDR Report Key4309746
Report Source06
Date Received2014-09-24
Date of Report2014-08-26
Date Mfgr Received2014-08-26
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 NameGEL-E DONUT - MEDIUM
Product CodeFMP
Date Received2014-09-24
Returned To Mfg2014-09-03
Model Number92025-C
Lot NumberUSE BY 2015/02/09 - NO PRO
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
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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