PRECISE PAIN RELIEVING HEAT PATCH UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-04-26 for PRECISE PAIN RELIEVING HEAT PATCH UNK manufactured by Kiribai Kobayashi Pharmaceutical Co, Ltd..

Event Text Entries

[2989254] This was a spontaneous self report from a (b)(6) female pt from the united states: (b)(4). Initial information was processed with additional information received on (b)(4) 2012. The pt's height was (b)(6) and weight was (b)(6). The pt's medical history and concurrent conditions included hysterectomy and no reaction on previous exposure to product as she "always used the product for her back and shoulder pain. " the pt had no known non drug allergies. The pt was treated with precise pain relieving heat patch (topical, batch (b)(4)) one patch as needed initiated on an unspecified date to (b)(6) 2012 for back and shoulder pain. Concomitant medications included premarin (estrogens conjugated) (formulation, route, dosage unspecified) one per day for two years initiated in 2010 for hormone replacement. On (b)(6) 2012, when the pt removed the patch from her shoulder, the adhesive tape pulled her skin off and made her bleed. The application site was a "greenish color" and hurt. The pt further described her shoulder as "looking really bad as if it was a second degree burn. " also, the pt had a "big scab. " the pt did not treat herself nor was seen in the emergency room. The pt noted that the adhesive tape/glue was too strong (product quality issue). Treatment with precise pain relieving heat patch was withdrawn. The pt had not recovered from the events. This report was serious (medically significant) and reportable (malfunction).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3003120375-2012-00379
• MDR Report Key: 2722764
• Report Source: 04
• Date Received: 2012-04-26
• Date of Report: 2012-04-26
• Date of Event: 2012-04-10
• Date Facility Aware: 2012-04-12
• Report Date: 2012-04-20
• Date Reported to FDA: 2012-04-20
• Date Reported to Mfgr: 2012-04-20
• Date Mfgr Received: 2012-04-12
• Date Added to Maude: 2012-09-04
• 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 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: 3

Device Details

• Brand Name: PRECISE PAIN RELIEVING HEAT PATCH
• Generic Name: NONE
• Product Code: OMW
• Date Received: 2012-04-26
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: BJC034
• 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

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2012-04-26