MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2012-05-22 for PRECISE PAIN RELIEVING HEAT PATCH UNK manufactured by Kiribai Kobayashi Pharmaceutical Co, Ltd.
[52867737]
This was a spontaneous report from a physician via a company rep and concerned a pt of an unspecified age and sex from the united states: (b)(4). The pt's height, weight, and medical history were not reported. The pt was treated with precise pain relieving heat patch (topical, dosage and frequency unspecified) initiated on an unspecified date for an unspecified indication. Concomitant medications were not reported. On an unspecified date, "the product caused the pt's skin to burn. " action taken with precise pain relieving heat patch was unspecified. The pt outcome was unspecified for skin burn. This report was serious (medically significant) and reportable (serious injury).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003120375-2012-00465 |
| MDR Report Key | 2586890 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2012-05-22 |
| Date of Report | 2012-05-14 |
| Date Facility Aware | 2012-05-14 |
| Report Date | 2012-05-17 |
| Date Reported to FDA | 2012-05-17 |
| Date Reported to Mfgr | 2012-05-17 |
| Date Mfgr Received | 2012-05-14 |
| Date Added to Maude | 2012-05-24 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer City | DALTON GA 30721 |
| Manufacturer Country | US |
| Manufacturer Postal | 30721 |
| Manufacturer Phone | 8004328629 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PRECISE PAIN RELIEVING HEAT PATCH |
| Generic Name | ADHESIVE BACKED THERMAL SKIN PATCHES |
| Product Code | OMW |
| Date Received | 2012-05-22 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KIRIBAI KOBAYASHI PHARMACEUTICAL CO, LTD |
| Manufacturer Address | SANDA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-05-22 |