MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-06-29 for ELVAREX CCL 2, KNEE HIGH, OPEN TOE, COLOR BLUE manufactured by .
[2771337]
Patient reports adverse reaction like blisters and rashes at both legs ("allergy") after he started to wear medical compression stockings for > 3 hours (reported in a letter to bsn - (b)(4) received 06/19/2012). Therapy date: (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[10022665]
Actual device was returned to manufacturer and will be sent to laboratory to undergo epicutan test following din en iso 10993-10:2010-12.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8043565-2012-00001 |
| MDR Report Key | 2655585 |
| Report Source | 04 |
| Date Received | 2012-06-29 |
| Date of Report | 2012-06-28 |
| Date of Event | 2012-05-30 |
| Date Mfgr Received | 2012-06-19 |
| Device Manufacturer Date | 2011-12-21 |
| Date Added to Maude | 2012-08-07 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | BEIERSDORFSTRASSE 1 |
| Manufacturer City | EMMERICH D-46446 |
| Manufacturer Postal | D-46446 |
| Manufacturer Phone | 822607121 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELVAREX CCL 2, KNEE HIGH, OPEN TOE, COLOR BLUE |
| Generic Name | MEDICAL COMPRESSION STOCKINGS |
| Product Code | DWL |
| Date Received | 2012-06-29 |
| Device Expiration Date | 2014-12-21 |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-06-29 |