3M SYNTHETIC CAST PADDING CMWO6

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 2013-02-21 for 3M SYNTHETIC CAST PADDING CMWO6 manufactured by 3m Health Care.

Event Text Entries

[22042898] Customer reported a female patient with a leg cast was itchy and had open wounds under the cast. The female patient was reportedly treated with an oral antibiotic and wet to dry gauze was applied. No further information was obtained.
Patient Sequence No: 1, Text Type: D, B5


[22198737] No lot number was provided and without this information it is not possible to determine the required information in these sections as to the manufactured date and/or expiration date.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2110898-2013-00008
MDR Report Key2981117
Report Source06
Date Received2013-02-21
Date of Report2013-02-01
Date of Event2013-01-28
Date Mfgr Received2013-02-01
Date Added to Maude2013-02-28
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 ContactLINDA JOHNSON, SPECIALIST
Manufacturer Street3M CENTER, BLDG. 275-5W-06
Manufacturer CityST. PAUL MN 551441000
Manufacturer CountryUS
Manufacturer Postal551441000
Manufacturer Phone6514303467
Manufacturer G1ROGERS CORPORATION
Manufacturer StreetONE TECHNOLOGY DRIVE
Manufacturer CityROGERS CT 06263021
Manufacturer CountryUS
Manufacturer Postal Code06263 0217
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name3M SYNTHETIC CAST PADDING
Generic Name(ITG) PROSTHETIC AND ORTHOTIC ACCESSORY
Product CodeITG
Date Received2013-02-21
Model NumberNA
Catalog NumberCMWO6
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
Manufacturer3M HEALTH CARE
Manufacturer AddressST. PAUL MN 55144 US 55144


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2013-02-21

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