MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-08-27 for 3M? TEGADERM? I.V. ADVANCED SECUREMENT DRESSING N/A 1685 manufactured by 3m Health Care.
[118283163]
Reporter contact information was not provided. End of report.
Patient Sequence No: 1, Text Type: N, H10
[118283164]
A hospital in (b)(6) reported a 1685 tegaderm iv advanced securement dressing was applied to a patient's picc catheter site. The patient reportedly experienced contact dermatitis under the area where the dressing was applied. The picc catheter was removed and replaced with a peripheral venous catheter. The picc site was treated with topical rx mometasone and the reaction has reportedly resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2018-00084 |
| MDR Report Key | 7818221 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-08-27 |
| Date of Report | 2018-08-27 |
| Date of Event | 2018-06-07 |
| Date Mfgr Received | 2018-08-08 |
| Device Manufacturer Date | 2017-07-01 |
| Date Added to Maude | 2018-08-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DIANNE GIBBS |
| Manufacturer Street | 275 5W-06 2510 CONWAY AVE |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517379117 |
| Manufacturer G1 | 3M COMPANY BROOKINGS |
| Manufacturer Street | 601 22ND AVE SOUTH |
| Manufacturer City | BROOKINGS SD 57006 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 57006 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M? TEGADERM? I.V. ADVANCED SECUREMENT DRESSING |
| Generic Name | TEGADERM? I.V. ADVANCED SECUREMENT DRESSING |
| Product Code | KMK |
| Date Received | 2018-08-27 |
| Model Number | N/A |
| Catalog Number | 1685 |
| Lot Number | 2019-07 XI |
| Device Expiration Date | 2019-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | 2510 CONWAY AVE ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-27 |