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 2018-03-01 for KROGER UPC#041260370755 20589 manufactured by Aso Llc.
[101340891]
As of (b)(6) 2018 consumer did not return unused samples for further investigation. Aso reviewed records of biocompatibility tests on materials used to manufacture the same type of product. Refer to section for further details.
Patient Sequence No: 1, Text Type: N, H10
[101340892]
Consumer reported that product caused skin irritation on her nose. She wore the product for about 8 hours.
Patient Sequence No: 1, Text Type: D, B5
[118006481]
As of 02/19/2018 consumer did not return unused samples for further investigation. Aso reviewed records of biocompatibility tests on materials used to manufacture the same type of product. As of 03/30/2018 received completed cir from the consumer with confirmation of the lot number and unused product. The correct product of this complaint is extra strength tan nasal strips. Suspect medical device was corrected. Unused returned product and retained samples were submitted to the lab for testing in addition to evaluate biocompatibility testing. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[118006482]
Consumer reported that product caused skin irritation on her nose. She wore the product for about 8 hours.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038758-2018-00005 |
| MDR Report Key | 7308172 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2018-03-01 |
| Date of Report | 2018-01-25 |
| Date of Event | 2018-01-17 |
| Date Mfgr Received | 2018-01-25 |
| Device Manufacturer Date | 2017-12-12 |
| Date Added to Maude | 2018-03-01 |
| 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 | MR. FEDERICO JULIAO |
| Manufacturer Street | 300 SARASOTA CENTER BLVD. |
| Manufacturer City | SARASOTA FL 34240 |
| Manufacturer Country | US |
| Manufacturer Postal | 34240 |
| Manufacturer G1 | ASO LLC |
| Manufacturer Street | 300 SARASOTA CENTER BLVD. |
| Manufacturer City | SARASOTA FL 34240 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 34240 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KROGER |
| Generic Name | EXTRA STRENGTH NASAL STRIPS |
| Product Code | LWF |
| Date Received | 2018-03-01 |
| Model Number | UPC#041260370755 |
| Catalog Number | 20589 |
| Lot Number | 00077490 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-03-01 |