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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 3M HEALTH CARE 3M COMPLY LEAD FREE INDICATOR TAPE; STERILIZATION PROCESS INDICATOR
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3M HEALTH CARE 3M COMPLY LEAD FREE INDICATOR TAPE; STERILIZATION PROCESS INDICATOR Back to Search Results
Catalog Number 1355-18MM
Device Problem Insufficient Information (3190)
Patient Problems Irritation (1941); Skin Irritation (2076)
Event Date 11/03/2014
Event Type  Injury  
Event Description
A female employee in the hospital sterile processing department used an indicator tape.About 6 weeks ago the customer alleged redness, burning and irritation on her hands, primarily on the fingers.The alleged skin irritation was worse on the right hand; the customer is right-handed.She reported that the skin irritation would resolve over the weekend when she was not at work, and would recur when she returned to work.The customer was given a prescription hydrocortisone which has helped with the skin irritation.She is now wearing gloves and the skin irritation has not returned.The customer has no history of skin sensitivities or latex allergy.
 
Manufacturer Narrative
Results: no code could be identified.The evaluation has not been conducted as of the date of this report and is pending.Conclusion not yet available- evaluation in process.The device is undergoing an evaluation but has not yet been completed.A follow-up report will be submitted once the evaluation of the returned product is completed.The actual product used was received on 12/23/2014.End of report.
 
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Brand Name
3M COMPLY LEAD FREE INDICATOR TAPE
Type of Device
STERILIZATION PROCESS INDICATOR
Manufacturer (Section D)
3M HEALTH CARE
2510 conway ave,
st. paul MN 55144 100
Manufacturer (Section G)
3M CANADA COMPANY
60 california ave. bldg 501
brockville ontario K6V 5W1
CA   K6V 5W1
Manufacturer Contact
linda johnsen, reg affairs
3m center, bldg. 275-5w-06
st. paul, MN 55144-1000
6517374376
MDR Report Key4381343
MDR Text Key5124640
Report Number2110898-2014-00088
Device Sequence Number1
Product Code JOJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101528
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 12/05/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/01/2015
Device Catalogue Number1355-18MM
Device Lot Number2015-12 RY
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/23/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/05/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial
Patient Sequence Number1
Treatment
NONE SPECIFIED.
Patient Outcome(s) Other;
Patient Age38 YR
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