MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-06-15 for PRECISE PAIN RELIEVING HEAT PATCH UNK manufactured by Kiribai Kobayashi Pharmaceutical Co, Ltd..
[53040267]
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
[53040268]
This was a spontaneous report from a (b)(6) male patient reporting on himself. The consumer applied one precise pain relieving heat patch (no active ingredient) for six to seven hours on (b)(6) 2011 for hip pain. The consumer reported when he removed the product that same day, he noticed three burn marks; in which one burn was the "size of a pencil" and the other two were about a quarter size. Also, his skin "came right off" with the patch. On an unspecified date, the patient treated the burn marks with a cream salve. The product use was discontinued on (b)(6) 2011. As of (b)(6) 2011, the outcome of the events was not resolved. This case is serious (medically significant). Additional information was received from an attorney on 09/02/2011. (b)(4) are duplicates. This and all subsequent relevant information will be submitted under (b)(4). This initial report form 01/13/2011 include additional information from 09/02/2011 (combined). Case updated with attorney contact information. Additional information was received from an attorney on 01/23/2012. No new information was updated as pictures of the patient and of the product were provided. This update was not regulatory relevant. Additional information was received on 04/18/2012 and contained no new information. No new information was added to case. Version 2 was created in error. Additional information was received on 06/08/2012 as an additional attorney with address was added.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003120375-2012-00585 |
| MDR Report Key | 2624395 |
| Date Received | 2012-06-15 |
| Date of Report | 2012-06-08 |
| Date of Event | 2011-01-12 |
| Date Facility Aware | 2011-01-13 |
| Report Date | 2012-06-08 |
| Date Reported to FDA | 2012-06-08 |
| Date Reported to Mfgr | 2012-06-08 |
| Date Mfgr Received | 2012-06-08 |
| Date Added to Maude | 2012-06-21 |
| 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 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 | 2012-06-15 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | 1001193 |
| ID Number | UNK |
| Device Expiration Date | 2012-12-31 |
| 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 | 2012-06-15 |