MAUDE Adverse Event Report: OMRON HEALTHCARE CO., LTD POCKET PAIN PRO; TENS

Model Number PM400

Device Problem Excessive Heating (4030)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 08/10/2023

Event Type  Injury  

Event Description

The consumer stated she bought the unit on friday (b)(6) 2023.She put the pads on her lower back/buttocks that night and woke up with the burns.She stated it seemed to be a first degree burn and was waiting in the burn clinic waiting room on (b)(6) 2023 during the time of the initial call.She stated her skin was bumpy and swollen where the pads were.She kept stating there were vesicles and mentioned she thought it was a second degree burn.She stated she followed the instructions several times and stated that there is nothing in the instructions that states she might get burned by the unit except if she was using another unit, which she was not.She stated it was definitely an electrical burn.She had the tens unit on 1 and stated it was not painful.She stated she was doctor and had to take off work due to the burn.She stated she had been a doctor for 25 years and stated it was a second degree burn.She had pain for three days and tingling in her leg that she was not sure was a result of the tens unit.During a follow-up call, the consumer stated that she was a doctor.She stated she could have permanent damage and that her injury can be a second degree burn.Her burn was looked at by an attending and fellow plastic surgeon at the burn clinic and she was told by them it was either a first degree or second degree burn.She was told to take motrin and use moisturizer.She stated she had the pads on her left buttocks and turned the tens to 1 or 2 for 10 minutes.She stated it helped with the pain and she may have moved the pads a bit lower.The next morning she noticed the burns in the shape of the pads (butterfly shaped) that had welts and was swollen.She stated the burn was painful and there were vesicles.She stated she could not sleep on her left side and her buttocks was still swollen as of (b)(6) 2023.She stated she was concerned the damage was permanent.She stated she was keeping the unit.

Manufacturer Narrative

A root cause has not been determined.It has not been confirmed if the device caused or contributed to the reported incident; however, due to the customer reporting having burns this medwatch is being filed.The consumer was offered a replacement unit or refund, and she declined.The product instruction manual includes following warnings: the mere existence of pain functions as a very important warning telling us that something is wrong.Therefore, if you suffer from any serious illness, consult your physician in order to confirm that it is advisable for you to use this unit.If you experience any skin irritation or redness after a session, do not continue stimulation in that area of the skin.Place pads on either side of the pain, not directly on the pain.Do not use this unit during these activities when in the bath or shower; while sleeping; while driving, operating machinery, or during any activity in which electrical stimulation can put you at risk of injury.Possible adverse reactions: you should stop using the unit and consult with your physician if you experience adverse reactions from the unit.You may experience skin irritation and burns beneath the stimulation electrodes applied to your skin.

Event Description

The consumer stated she bought the unit on friday 8/10/2023.She put the pads on her lower back/buttocks that night and woke up with the burns.She stated it seemed to be a first degree burn and was waiting in the burn clinic waiting room on (b)(6) 2023 during the time of the initial call.She stated her skin was bumpy and swollen where the pads were.She kept stating there were vesicles and mentioned she thought it was a second degree burn.She stated she followed the instructions several times and stated that there is nothing in the instructions that states she might get burned by the unit except if she was using another unit, which she was not.She stated it was definitely an electrical burn.She had the tens unit on 1 and stated it was not painful.She stated she was doctor and had to take off work due to the burn.She stated she had been a doctor for 25 years and stated it was a second degree burn.She had pain for three days and tingling in her leg that she was not sure was a result of the tens unit.During a follow-up call, the consumer stated that she was a doctor.She stated she could have permanent damage and that her injury can be a second degree burn.Her burn was looked at by an attending and fellow plastic surgeon at the burn clinic and she was told by them it was either a first degree or second degree burn.She was told to take motrin and use moisturizer.She stated she had the pads on her left buttocks and turned the tens to 1 or 2 for 10 minutes.She stated it helped with the pain and she may have moved the pads a bit lower.The next morning she noticed the burns in the shape of the pads (butterfly shaped) that had welts and was swollen.She stated the burn was painful and there were vesicles.She stated she could not sleep on her left side and her buttocks was still swollen as of (b)(6) 2023.She stated she was concerned the damage was permanent.She stated she was keeping the unit.The consumer called again with additional information on 8/30/2023.She stated she had scarring and some bumpiness under the skin still.She stated she is not hurting, and it is cosmetic at the moment.She stated she now has weakness in her left leg, mostly in the thigh area, but she was not sure it was due to the unit or not.She stated she felt twitchy in her leg, but she was not ready to blame the machine since she was not sure it was the cause.She did go to another doctor and that she would be going for x-rays since the doctor did not know how to handle the issue with the burns.She stated she wanted her money back, but a refund was not going to be satisfactory so no refund was issued at the time.She stated she did not wash the pads prior to using them or apply moisturizer.She stated she used moisturizer in general and used it to treat the burn per her doctor's instructions.She stated she was treating persistent anterior side pain.

Manufacturer Narrative

The device was not returned to the distributor/manufacturer for investigation and the investigation was closed on 12/08/2023.Here is the summary of the manufacturer device investigation: the manufacturer shipping inspection was reviewed and the inspection for the lot including this unit serial number passed.The risk analysis document was reviewed and similar risk has been analyzed.There was no similar event reported for the same model in the past.Unit was not returned by consumer.The device was not received for evaluation; therefore, a device analysis could not be completed.No further investigation required.Importer report #: (b)(4).

Event Description

The consumer stated she bought the unit on friday (b)(6) 2023.She put the pads on her lower back/buttocks that night and woke up with the burns.She stated it seemed to be a first degree burn and was waiting in the burn clinic waiting room on (b)(6) 2023 during the time of the initial call.She stated her skin was bumpy and swollen where the pads were.She kept stating there were vesicles and mentioned she thought it was a second degree burn.She stated she followed the instructions several times and stated that there is nothing in the instructions that states she might get burned by the unit except if she was using another unit, which she was not.She stated it was definitely an electrical burn.She had the tens unit on 1 and stated it was not painful.She stated she was doctor and had to take off work due to the burn.She stated she had been a doctor for 25 years and stated it was a second degree burn.She had pain for three days and tingling in her leg that she was not sure was a result of the tens unit.During a follow-up call, the consumer stated that she was a doctor.She stated she could have permanent damage and that her injury can be a second degree burn.Her burn was looked at by an attending and fellow plastic surgeon at the burn clinic and she was told by them it was either a first degree or second degree burn.She was told to take motrin and use moisturizer.She stated she had the pads on her left buttocks and turned the tens to 1 or 2 for 10 minutes.She stated it helped with the pain and she may have moved the pads a bit lower.The next morning she noticed the burns in the shape of the pads (butterfly shaped) that had welts and was swollen.She stated the burn was painful and there were vesicles.She stated she could not sleep on her left side and her buttocks was still swollen as of (b)(6) 2023.She stated she was concerned the damage was permanent.She stated she was keeping the unit.The consumer called again with additional information on 8/30/2023.She stated she had scarring and some bumpiness under the skin still.She stated she is not hurting, and it is cosmetic at the moment.She stated she now has weakness in her left leg, mostly in the thigh area, but she was not sure it was due to the unit or not.She stated she felt twitchy in her leg, but she was not ready to blame the machine since she was not sure it was the cause.She did go to another doctor and that she would be going for x-rays since the doctor did not know how to handle the issue with the burns.She stated she wanted her money back, but a refund was not going to be satisfactory so no refund was issued at the time.She stated she did not wash the pads prior to using them or apply moisturizer.She stated she used moisturizer in general and used it to treat the burn per her doctor's instructions.She stated she was treating persistent anterior side pain.The consumer called on (b)(6) 2023.She stated she received an e-mail stating that she was told to stop using the unit.She stated that it was not true that she was told that.She did not want any more emails.She was advised that in order to investigate the issue further, she would need to send in her unit for inspection.She refused and stated she was keeping the unit for evidence.She did not want a replacement unit or a refund.No further contact has been received from the consumer.

• Brand Name: POCKET PAIN PRO
• Type of Device: TENS
• Manufacturer (Section D): OMRON HEALTHCARE CO., LTD; 53 kunotsubo; terado-cho; muko-city, kyoto 61700 02; JA 6170002
• Manufacturer (Section G): OMRON HEALTHCARE CO., LTD; 53 kunotsubo; terado-cho; muko-city, kyoto 61700 02; JA 6170002
• Manufacturer Contact: tomoji zukawa ; 53 kunotsubo; terado-cho; muko-city, kyoto 61700-02 ; JA 6170002
• MDR Report Key: 17667458
• MDR Text Key: 322468309
• Report Number: 8030245-2023-00005
• Device Sequence Number: 1
• Product Code: NUH
• UDI-Device Identifier: 00073796634001
• UDI-Public: (01)00073796634001
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K181992
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PM400
• Device Catalogue Number: PM400
• Device Lot Number: 202306V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Sex: Female