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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN COVIDIEN TELFA NON-ADHERENT PAD PRE-PACK 8"X3" BOXES OF 50 DRESSING, WOUND, OCCLUSIVE

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COVIDIEN COVIDIEN TELFA NON-ADHERENT PAD PRE-PACK 8"X3" BOXES OF 50 DRESSING, WOUND, OCCLUSIVE Back to Search Results
Catalog Number 1238
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/23/2019
Event Type  malfunction  
Event Description
I do not know if this is the proper place to report this, or if the report should be a product safety issue. The source of the problem is not with the mfr, but with the seller. Two packages of supposedly sterile wound dressings arrived via usps from (b)(6) that had been opened and not resealed in a sanitary manner, despite the box label stating not to use if package is opened or damaged. (photos attached) the problem clearly originated with (b)(6), not (b)(6). Furthermore, subsequent reading of product reviews on (b)(6) website indicates that (b)(6) has been aware that they are opening and shipping originally sterile items inappropriately for some time. (reviews are included with this form). (b)(6) refuses to allow returns of the items or to replace with unopened packages. Since the packages have been opened by the shipper. I am concerned that they are no longer safe to use on open wounds. As this is a pattern of product handling by (b)(6), i am concerned that add'l purchasers may be using non-sterile dressings on their wounds and lesions. Covidien telfa non-adherent pad pre-pack 8"x3" boxes of 50. Again, the issue is not with the mfr, only with tampering by the seller / shipper, (b)(6).
 
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Brand NameCOVIDIEN TELFA NON-ADHERENT PAD PRE-PACK 8"X3" BOXES OF 50
Type of DeviceDRESSING, WOUND, OCCLUSIVE
Manufacturer (Section D)
COVIDIEN
MDR Report Key9179908
MDR Text Key162356805
Report NumberMW5090348
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 09/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1238
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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