MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2018-02-27 for POCKET PAIN PRO PM3029 manufactured by Omron (dalian) Co., Ltd. (plant 2).
[101117891]
(b)(4). Unit has been received and device evaluation is in progress. Consumer admitted using the device off label. The u. S importer is requesting the manufacturer of the device to further investigate this incident. The product labeling states the following under important safety precautions and warnings: " never apply the pads to these body areas: the neck or any area of the throat because this could cause severe muscle spasms resulting in closure of the airway, difficulty in breathing, or adverse effects on heart rhythm or blood pressure. " a root cause has not been determined. It has not been confirmed whether the device caused or contributed to the reported incident. However, due to the customer using the device off label and calling an ambulance and getting treatment for increased heart rate, this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
[101117892]
Consumer reported she used her unit for an hour on her neck area on (b)(6) 2018. She woke up with her heart racing and called an ambulance. When she was in the ambulance, they hooked her up to an ekg and iv. They gave her medication but she does not know what it was. There was no change with single dose of the medication, so they doubled the dose. Consumer stated by the time she arrived at the hospital, everything was normal. They did ekg, x-ray and blood work. She was advised to follow up with her physician. Consumer stated when she used her unit; she sat on her recliner or rocking chair. She was using the unit for 15 minutes once a day. Consumer stated she has given the unit to her doctor but she will try to get it back and send it for further investigation. Customer service representative informed consumer that postage paid label is sent to her to retrieve the unit. During follow-up call with quality analyst, consumer stated she put the pads on her neck and ended up calling an ambulance and going to er. She has had the unit since the fall, and was the only user, and used the unit normally 5 times a week with 15 minute sessions. She used the unit on her trapezius muscles for an hour straight on (b)(6). She has degenerative disks so she had to use it on her trapezius area. Consumer stated this is all her fault because she used the pads for an hour straight and read the instruction manual after all of this and noticed it states to not put on your neck area. Consumer stated the ambulance gave her pills because her heart rate was 212. When she got to hospital, they did ekg, blood work and everything came back normal. She called her cardiologist and she had to wear a heart monitor at night but the results came back normal. Consumer would like a refund. A postage paid label has been sent for retrieval of the home unit for inspection. During follow-up call on (b)(6) 2018 with quality department consumer stated she has already mailed the unit back for inspection so cannot provide serial lot number. Consumer insisted that it was her own fault, she had misused the unit. She has been on atenolol for hypertension and lipitor for high cholesterol. Consumer was using the unit since fall but was using on her shoulder and this time she used it all the way up on her neck. Consumer repeatedly stated it was her fault. Consumer indicated when she used it "properly" she really liked it and it helped her a lot; she was able to get good night sleep. Consumer did not remember name of the medication she was given in the ambulance but it was to control her heart rate. She does not have pacemaker or any implanted metallic or electronic devices. Consumer again stated she is a retired teacher and she should know that she should be reading the instructions prior to using the unit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003263296-2018-00002 |
| MDR Report Key | 7300559 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2018-02-27 |
| Date of Report | 2018-02-27 |
| Date of Event | 2018-01-09 |
| Date Facility Aware | 2018-02-15 |
| Date Mfgr Received | 2018-04-06 |
| Device Manufacturer Date | 2017-05-14 |
| Date Added to Maude | 2018-02-27 |
| 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 Contact | MS. RENEE THORNBOROUGH |
| Manufacturer Street | 1925 W FIELD COURT SUITE 100 |
| Manufacturer City | LAKE FOREST IL 600454824 |
| Manufacturer Country | US |
| Manufacturer Postal | 600454824 |
| Manufacturer Phone | 8472475626 |
| Manufacturer G1 | OMRON (DALIAN) CO., LTD. (PLANT 2) |
| Manufacturer Street | NO. 28 DONGBEI ER STREET, ECO- NOMIC & TECHNICAL DEVELOPMENT |
| Manufacturer City | DALIAN LIAONING, 116600 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 116600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POCKET PAIN PRO |
| Generic Name | TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR T.E.N.S |
| Product Code | NUH |
| Date Received | 2018-02-27 |
| Returned To Mfg | 2018-02-27 |
| Model Number | PM3029 |
| Catalog Number | PM3029 |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 8 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OMRON (DALIAN) CO., LTD. (PLANT 2) |
| Manufacturer Address | NO. 28 DONGBEI ER STREET, ECO- NOMIC & TECHNICAL DEVELOPMENT DALIAN LIAONING, 116600 CH 116600 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-02-27 |