MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2010-08-04 for PRECISE PAIN RELIEVING HEAT PATCH manufactured by Kiribai Kobayashi Pharmaceutical Co. Ltd.
[1372450]
This was a spontaneous report from a (b)(6) female consumer reporting on herself. The consumer reported using two precise pain relieving heat patch (no active ingredient) once on (b)(6)-2010 for lower back pain (l1). The following day, the application site area was red and a burn was noticed by her husband, daughter, and care giver. As treatment, bacitracin cream was applied to stop the burning. As of (b)(6)-2010, the outcome of the events were not resolved. This case is serious (medically significant). This case version was created for the purposes of quality improvement. Upon review, the following correction was made: previously reported initial received date was updated to (b)(6) 2010. Additional info was received from the consumer on 27-jul-2010. On an unk date, the consumer was hospitalized for burn caused from the product. On (b)(6)-2010, she was discharged. The consumer also reported at the application site "the skin came off". At the time of reporting, the outcome of the event was not resolved. This case is serious (hospitalization and medically significant).
Patient Sequence No: 1, Text Type: D, B5
[8756578]
At this time the device has not been returned for failure analysis/laboratory testing. Given the circumstances of the reported event(s) and the known mechanism of action of the device, a causal association with the device is possible.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003120375-2010-00001 |
| MDR Report Key | 1840274 |
| Report Source | 04 |
| Date Received | 2010-08-04 |
| Date of Report | 2010-07-23 |
| Date of Event | 2010-07-22 |
| Date Facility Aware | 2010-07-22 |
| Report Date | 2010-07-23 |
| Date Reported to FDA | 2010-07-23 |
| Date Mfgr Received | 2010-07-27 |
| Date Added to Maude | 2010-09-22 |
| 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 | 3 |
| Manufacturer Street | 185 TABOR ROAD |
| Manufacturer City | MORRIS PLAINS NJ 07950 |
| Manufacturer Country | US |
| Manufacturer Postal | 07950 |
| Manufacturer Phone | 2153257685 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRECISE PAIN RELIEVING HEAT PATCH |
| Generic Name | HOT OR COLD DISPOSABLE PACK |
| Product Code | OMW |
| Date Received | 2010-08-04 |
| Lot Number | BEC003 |
| Device Expiration Date | 2012-12-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KIRIBAI KOBAYASHI PHARMACEUTICAL CO. LTD |
| Manufacturer Address | 18-9 TEKUNOPARK SANDA, JP-28 669-1339 JA 669-1339 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2010-08-04 |