MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-22 for WALGREENS PERSONAL WARM STEAM INHALER PJ1011 manufactured by Povos.
[5878223]
According to a complaint forwarded to walgreens by the product supplier, (b)(4), the consumer sustained burns to her face, lips, and chin area while using this product (b)(4). The product named in this complaint is the walgreens personal steam inhaler (walgreens wic (b)(4)).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1460851-2015-00002 |
| MDR Report Key | 4795517 |
| Date Received | 2015-05-22 |
| Date of Report | 2015-05-22 |
| Date of Event | 2015-03-11 |
| Date Facility Aware | 2015-05-12 |
| Report Date | 2015-05-22 |
| Date Reported to FDA | 2015-05-22 |
| Date Reported to Mfgr | 2015-05-22 |
| Date Added to Maude | 2015-05-27 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 0 |
| Manufacturer Street | 200 WILMOT RD. |
| Manufacturer City | DEERFIELD IL 60015 |
| Manufacturer Country | US |
| Manufacturer Postal | 60015 |
| Manufacturer G1 | WALGREEN CO. |
| Manufacturer Street | 200 WILMOT RD. |
| Manufacturer City | DEERFIELD IL 60015 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60015 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WALGREENS PERSONAL WARM STEAM INHALER |
| Generic Name | STEAM INHALER |
| Product Code | KCO |
| Date Received | 2015-05-22 |
| Model Number | PJ1011 |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POVOS |
| Manufacturer Address | SHANGHAI CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-22 |