MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-03-12 for LEG HOLDER, PAIR 100586B0 manufactured by Holger Ullrich.
[138537330]
(b)(4). At the time of this report the investigation was still ongoing. As soon as the investigation is finished the report will be updated and a follow-up/final report will be provided to the fda.
Patient Sequence No: 1, Text Type: N, H10
[138537331]
It was reported that there was an incident with a leg holder. This resulted in the patient's foot to be injured. Further details regarding this event were requested, but are not yet available at the date of this report. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010652-2019-00011 |
| MDR Report Key | 8412495 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-03-12 |
| Date of Report | 2019-06-11 |
| Date of Event | 2019-03-01 |
| Date Mfgr Received | 2019-03-04 |
| Date Added to Maude | 2019-03-12 |
| 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 | 3 |
| Manufacturer Street | MAQUET GMBH KEHLER STRASSE 31, |
| Manufacturer City | RASTATT 76437 |
| Manufacturer Country | GM |
| Manufacturer Postal | 76437 |
| Manufacturer G1 | HOLGER ULLRICH |
| Manufacturer Street | MAQUET GMBH KEHLER STRASSE 31, |
| Manufacturer City | RASTATT 76437 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 76437 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEG HOLDER, PAIR |
| Generic Name | TABLE AND ATTACHMENTS, OPERATING-ROOM |
| Product Code | BWN |
| Date Received | 2019-03-12 |
| Model Number | 100586B0 |
| Catalog Number | 100586B0 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLGER ULLRICH |
| Manufacturer Address | MAQUET GMBH KEHLER STRASSE 31, RASTATT 76437 GM 76437 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-12 |