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 2019-04-12 for 3M? TEGADERM? I.V. ADVANCED SECUREMENT DRESSING N/A 1685 manufactured by 3m Health Care.
[141905004]
Date of event: (b)(6) 2019 was used for the date of event since the reported stated that the events occurred (b)(6) 2019. The report alleges allergic reactions which may have been the reason for the symptoms; however, shear stress related skin injury cannot be excluded with the limited amount of information available. End of report.
Patient Sequence No: 1, Text Type: N, H10
[141905005]
A customer reported that patients (number of patients unspecified) experienced alleged allergic reactions, reported as skin redness, itching and blistering in areas where the border adhesive came into contact with the skin after application of 1685 tegaderm iv advanced securement dressings. The symptoms began approximately six hours after initial application and resolved typically within 2-3 days. Treatment consisted of iv or oral antihistamines. The patients were undergoing chemotherapy and in some instances the dressing was difficult to remove since the skin was very fragile.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2019-00047 |
| MDR Report Key | 8511744 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-12 |
| Date of Report | 2019-04-12 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2019-03-19 |
| Device Manufacturer Date | 2017-07-01 |
| Date Added to Maude | 2019-04-12 |
| 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 | 2019-04-12 |
| Model Number | N/A |
| Catalog Number | 1685 |
| Lot Number | 2020-06A6 |
| 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 | 2019-04-12 |