[68964773]
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of burn infection ("i got a burn on my back / the burn got infected") in a (b)(6)-year-old female patient who received aleve tens device direct therapy unit (batch no. T05whv) for low back pain. The occurrence of additional non-serious events is detailed below. On an unknown date, the patient started aleve tens device direct therapy unit. In (b)(6) 2016, the patient experienced medical device site scab ("it started as a hard scab"). On (b)(6)2016, the patient experienced burn infection (seriousness criteria medically significant and clinically significant/intervention required) and medical device site swelling ("my back swelled"). In (b)(6) 2016, the patient experienced wound secretion ("the burn infected is still oozing"). The patient was treated with bactrim (sulfamethoxazole/trimethoprim) and antibiotics. Aleve tens device direct therapy unit was withdrawn. In 2016, the medical device site scab had resolved. In (b)(6) 2016, the medical device site swelling had resolved. At the time of the report, the burn infection and wound secretion had resolved. The reporter provided no causality assessment for burn infection, wound secretion and medical device site swelling with aleve tens device direct therapy unit. The reporter considered medical device site scab to be related to aleve tens device direct therapy unit. Quality-safety evaluation of ptc: the reported defect cannot be confirmed at this time. An investigation report has been requested of the cmo and additional time is needed identify the cause. A follow up has been created where the conclusive assessment will be finalized upon receipt. This procedure is in alignment with the current version of gsop 115. Product technical complaint occurred: aleve tens - electrical problems. (b)(4). Investigation reviewed. The ptc investigation was initiated and the outcome of the investigation resulted in an unconfirmed quality defect. Most recent follow-up information incorporated above includes: on 22-feb-2017: correction: the seriousness criterion of intervention required was added. Company causality comment this spontaneous case reported by a consumer described the occurrence of a burn infection ("i got a burn on my back / the burn got infected") in a (b)(6) year-old female patient who received aleve tens device direct therapy unit for low back pain. This event is serious due to medical importance and intervention required and unlisted in the reference safety information for aleve tens. No other consumer`s concurrent conditions and medical history were reported. Consumer reported that the event started as a hard scab and consumer thought it would go away, but it had gotten very infected. Consumer`s doctor referred her to a surgeon and she had the burn lanced. She took antibiotics for treatment and event recovered. In this context, considering the close temporal relationship and the lack of alternative explanation for event, causality of aleve tens cannot be excluded.
Patient Sequence No: 1, Text Type: D, B5