MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-01-11 for LEADER 9629611818 manufactured by Aso Llc.
[3223049]
On (b)(6) 2012, customer reported that the end-user claims having a severe allergy to the adhesive. On (b)(6) 2012, the end-user reported the device caused dermatitis that is not healing and hurts. The burning stopped gradually, but still has a square rash on her calf. Treated area with mupirocin 2%.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038758-2013-00003 |
| MDR Report Key | 2933218 |
| Report Source | 04 |
| Date Received | 2013-01-11 |
| Date of Report | 2013-01-09 |
| Date Mfgr Received | 2012-12-11 |
| Date Added to Maude | 2013-02-07 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 300 SARASOTA CENTER BLVD. |
| Manufacturer City | SARASOTA FL 34240 |
| Manufacturer Country | US |
| Manufacturer Postal | 34240 |
| Manufacturer Phone | 9413786656 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEADER |
| Generic Name | SHEER ADHESIVE PADS |
| Product Code | KGF |
| Date Received | 2013-01-11 |
| Returned To Mfg | 2012-12-31 |
| Model Number | 9629611818 |
| Lot Number | 2 1/10 59839 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASO LLC |
| Manufacturer Address | 300 SARASOTA CENTER BLVD. SARASOTA FL 34240 US 34240 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-01-11 |