MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-03-16 for CONAIR CORPORATION UNK manufactured by Conair Corp..
[18625987]
Consumer claims that she was using the heating pad for about 30min. She claims that she doze off and woke up with a pain on her shoulder. She touched her shoulder and broke a blister which had formed. She has two other spots that are burned on the shoulder. She initially put salve on the burns, but since she believes she has 3rd degree burns she will visit the er.
Patient Sequence No: 1, Text Type: D, B5
[18707342]
We are currently waiting for feedback from the consumer regarding the er visit. We will also request the product back from the consumer for eval. A supplementary report will be submitted upon final eval and new findings (if applicable). Note, however, that is clearly stated on the product and all the instruction manual that the consumer shall not fall sleep while using the product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222304-2014-00038 |
| MDR Report Key | 3764399 |
| Report Source | 04 |
| Date Received | 2014-03-16 |
| Date of Report | 2014-03-19 |
| Date of Event | 2014-03-10 |
| Date Mfgr Received | 2014-04-02 |
| Date Added to Maude | 2014-04-22 |
| 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 | 1 CUMMINGS POINT RD. |
| Manufacturer City | STAMFORD CT 06902 |
| Manufacturer Country | US |
| Manufacturer Postal | 06902 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONAIR CORPORATION |
| Generic Name | PARAFFIN BATH |
| Product Code | IMC |
| Date Received | 2014-03-16 |
| Model Number | UNK |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONAIR CORP. |
| Manufacturer Address | STAMFORD CT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-16 |