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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN XEROFRM GZE 4X3YD RL FOIL PK STRLPETROLATUM GAUZE

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COVIDIEN XEROFRM GZE 4X3YD RL FOIL PK STRL PETROLATUM GAUZE   Back to Search Results
Model Number 8884432000
Device Problem Flaked
Event Type  Other   Patient Outcome  Other
Event Description

It was reported to covidien on (b)(6) 2012, that a customer had an issue with a petrolatum gauze. The customer reports that upon removing the dressing from a wound, some fibers remained in the wound. The customer further reports, that the fibers were removed immediately with no ill effect to the pt.

 
Manufacturer Narrative

(b)(4). An investigation is currently underway. Upon completion, the results will be forwarded. Product monitoring contacted the customer requesting add'l info. Attempts were made to retrieve add'l info. However, the customer reports no other info of the event is available.

 
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Brand NameXEROFRM GZE 4X3YD RL FOIL PK STRL
Type of DevicePETROLATUM GAUZE
Manufacturer (Section F)
COVIDIEN
1430 marvin griffin road
augusta GA 30906
Manufacturer (Section D)
COVIDIEN
1430 marvin griffin road
augusta GA 30906
Manufacturer (Section G)
COVIDIEN
1430 marvin griffin road
augusta GA 30906
Manufacturer Contact
armando botelho
15 hampshire st.
mansfield , MA 02048
(508) 261 -6387
Device Event Key2871861
MDR Report Key2831319
Event Key2727895
Report Number1018120-2012-00018
Device Sequence Number1
Product CodeFRO
Report Source Manufacturer
Source Type User facility,Company Representative
Reporter Occupation UNKNOWN
Type of Report Initial
Report Date 10/08/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/02/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number8884432000
Device Catalogue Number8884432000
Device LOT Number120001762262X
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Device Age na
Event Location Hospital
Date Report TO Manufacturer10/08/2012
Date Manufacturer Received10/08/2012
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

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