MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2015-08-26 for DOLLAR GENERAL/REXALL UPC: 017276228090 00462401 manufactured by Aso Llc.
[24408916]
Product has a sturdy adhesive, not intended for sensitive skin, labeling on box disclosed this.
Patient Sequence No: 1, Text Type: N, H10
[24408917]
On (b)(6) 2015, the consumer/end user reported that the device product tore her skin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038758-2015-00066 |
| MDR Report Key | 5035603 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2015-08-26 |
| Date of Report | 2015-08-24 |
| Date Mfgr Received | 2015-07-28 |
| Device Manufacturer Date | 2013-05-11 |
| Date Added to Maude | 2015-08-27 |
| 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 Street | 300 SARASOTA CENTER BLVD. |
| Manufacturer City | SARASOTA FL 34240 |
| Manufacturer Country | US |
| Manufacturer Postal | 34240 |
| Manufacturer Phone | 9413790300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DOLLAR GENERAL/REXALL |
| Generic Name | WATERPROOF HEAVY FABRIC BANDAGES |
| Product Code | FPX |
| Date Received | 2015-08-26 |
| Model Number | UPC: 017276228090 |
| Catalog Number | 00462401 |
| Lot Number | 314503 |
| Device Expiration Date | 2018-05-10 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASO LLC |
| Manufacturer Address | SARASOTA FL 34240 US 34240 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-26 |