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

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).

• Brand Name: COVIDIEN TELFA NON-ADHERENT PAD PRE-PACK 8"X3" BOXES OF 50
• Type of Device: DRESSING, WOUND, OCCLUSIVE
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 9179908
• MDR Text Key: 162356805
• Report Number: MW5090348
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1238
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR