MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-09-13 for PATHWAY manufactured by Medoc Ltd..
[963015]
A healthy volunteer subject was receiving thermal heat stimulation to her right lower leg. The stimulus was delivered by the pathways device, rising from a baseline temp of 35c to a target temp of 48c, the pt experienced a burn. Although the subject was conscious, non-sedated, and in a lab setting, with free access to her leg, when the subject removed the probe, she had received a significant burn in the stimulated region (16x16mm) of skin. Upon inspection, there was a blister and obvious skin damage to the 16x16mm region of skin that was directly contacted by the stimulator, with redness around the periphery. Ice was applied and a physician opinion indicated that the burn was greater than 2nd degree and provided the subject with silvadene (sp) cream and analgesics. A follow-up appointment was arranged with the burn clinic.
Patient Sequence No: 1, Text Type: D, B5
[8198185]
The pathway stimulator has a failsafe cutoff that is activated when the stimulus temp exceeds a certain threshold (typically 54c). In this case it appears that this failsafe procedure was activated; however, the stimulator may have remained active/on despite the fact that the software notifications indicated that the stimulator was off. Medoc visited the incident site and investigated problem with the reported system. The system was then checked twice and was found to meet the performance requirements in that it passed self tests and safety protocols successfully. Nevertheless, medoc performed comprehensive service on the system in order to restore customer confidence. Although medoc could no re-create the condition which caused the situation, had the operator used the manual built in safety panic button, or the test subject (volunteer) would have used the extended pain button during the incident, the burn could have prevented. Meanwhile medoc considers this to be an isolated event in that it has had no other complaints of this nature and remains in close contact with its customers.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8044062-2008-00001 |
| MDR Report Key | 1171219 |
| Report Source | 05 |
| Date Received | 2008-09-13 |
| Date of Report | 2008-09-08 |
| Date of Event | 2008-08-13 |
| Date Mfgr Received | 2008-08-13 |
| Date Added to Maude | 2008-09-26 |
| 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 | 0 |
| Manufacturer Contact | GEORGE HATTUB, USA AGENT |
| Manufacturer Street | 291 HILLSIDE AVE. |
| Manufacturer City | SOMERSET MA 02726 |
| Manufacturer Country | US |
| Manufacturer Postal | 02726 |
| Manufacturer Phone | 5084796116 |
| Manufacturer G1 | MEDOC, LTD. |
| Manufacturer Street | 1 HA'DEKEL ST. POB 423 |
| Manufacturer City | RAMAT YISHAI 30095 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 30095 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PATHWAY |
| Generic Name | CONTACT/HEATEVOKED POTENTIAL STIMULATOR |
| Product Code | NTU |
| Date Received | 2008-09-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1200248 |
| Manufacturer | MEDOC LTD. |
| Manufacturer Address | 1 HA'DEKEL ST. POB 423 RAMAT YISHAI IS 30095 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-09-13 |