MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-05-09 for COBAN SELF-ADHERENT WRAP 1583 manufactured by 3m Health Care.
[44725296]
Customer from a dermatology clinic reported a 1583 coban self adherent wrap was used to secure a gauze dressing on a (b)(6) y/o male patient. Customer reported the patient experienced an allergic reaction (itching,redness, burning and rash) on his leg where the wrap touched his skin. The reaction was treated with a 15 day course of oral prednisone and was reportedly improving four days after medication was started.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2016-00057 |
| MDR Report Key | 5640851 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-05-09 |
| Date of Report | 2016-04-29 |
| Date of Event | 2016-04-25 |
| Date Mfgr Received | 2016-04-29 |
| Date Added to Maude | 2016-05-09 |
| 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 | MS KAREN KRENIK, BSN |
| Manufacturer Street | 3M CENTER BUILDING 275-5W-06 2510 CONWAY AVE |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517333091 |
| 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 | COBAN SELF-ADHERENT WRAP |
| Generic Name | COBAN WRAP |
| Product Code | FQM |
| Date Received | 2016-05-09 |
| Catalog Number | 1583 |
| 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 | 2016-05-09 |