MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-05-12 for INTELECT 2738 manufactured by Djo, Llc.
[15124264]
Initial report to mfr received from fda via uf/importer report # (b)(4). Complaint received from customer via fda that alleges "the pt returned five days later and point to lateral deltoid and 3 wounds were noted with the largest measuring 2cm x 1cm. All wounds were clean, closed with scabbing noted no drainage. The largest wound noted to have clean and well defined margins with the scabbing noted more medially. Margins appeared pink and not red in color". "the pt stated that he had forgotten that his wife has used a muscle rub on his shoulder and he forgot to inform us. " questionnaire not received from clinician and/or patient. Product not returned to mfr for review. No indication event caused or contributed to permanent impairment, serious injury or death. No indication device caused or contributed to the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2014-00010 |
| MDR Report Key | 3854017 |
| Report Source | 99 |
| Date Received | 2014-05-12 |
| Date of Report | 2014-05-12 |
| Date of Event | 2014-03-28 |
| Date Added to Maude | 2014-06-20 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 1430 DECISION STREET |
| Manufacturer City | VISTA CA 92081 |
| Manufacturer Country | US |
| Manufacturer Postal | 92081 |
| Manufacturer Phone | 7607271280 |
| Manufacturer G1 | DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. |
| Manufacturer Street | CARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO |
| Manufacturer City | TIJUANA 22244 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22244 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTELECT |
| Generic Name | STIMULATOR, ULTRASOUND AND MUSCLE |
| Product Code | IPF |
| Date Received | 2014-05-12 |
| Model Number | 2738 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO, LLC |
| Manufacturer Address | 1430 DECISION STREET VISTA CA 92081 US 92081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-05-12 |