MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1999-12-09 for BURDICK D-900 NA manufactured by .
[145691]
Pt allegedly sustained two circular burns (approx 4cm) to left posterior shoulder. It was reported that the pt had been undergoing treatment with the d-900 for about 2 weeks, for approx 10 to 15 min each session. Nurse could not recall the distance that the d-900's applicator was held from the pt's skin, but nurse claimed there was enough distance for the technician to slide the hand between the applicator and the pt. Nurse didn't remember the d-900's power setting.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2112020-1999-00004 |
| MDR Report Key | 258553 |
| Report Source | 05,06 |
| Date Received | 1999-12-09 |
| Date of Event | 1999-07-06 |
| Date Mfgr Received | 1999-11-15 |
| Device Manufacturer Date | 1979-03-01 |
| Date Added to Maude | 2000-01-18 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SUSAN LUCHT-JOHNSON |
| Manufacturer Street | 500 BURDICK PKWY |
| Manufacturer City | DEERFIELD WI 53531 |
| Manufacturer Country | US |
| Manufacturer Postal | 53531 |
| Manufacturer Phone | 8007771777 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BURDICK |
| Generic Name | D-900 SHORT WAVE DIATHERMY |
| Product Code | IMJ |
| Date Received | 1999-12-09 |
| Model Number | D-900 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 250379 |
| Baseline Brand Name | BURDICK |
| Baseline Generic Name | D-900 SHORT WAVE DIATHERMY |
| Baseline Model No | D-900 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-12-09 |