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 2019-02-12 for PRONE HEADREST 40061900 manufactured by Holger Ullrich.
[135912385]
(b)(4). Pressure ulcers can be caused due to different influences (preexisting medical conditions, patient age, duration of the position, unfavorable positioning of the patient, etc. ). No damage or malfunction of the used gel pad was reported. In the instructions for use (ifu) the user is warned regarding the risks related to improper patient positioning. Quote ifu: "warning! Risk of injury! Improper patient positioning may cause health damage (e. G. Decubitus). Position the patient correctly and keep under constant observation. " no malfunction of the (b)(4) - maquet device was reported. We assume that in this case several unfavorable factors came together and thus led to the described injury. Since an injury was reported to (b)(4) - maquet we decided to report tis case to the competent authorities. (b)(4) -maquet provides product failure investigation, analysis and resolution for the device described in this report.
Patient Sequence No: 1, Text Type: N, H10
[135912386]
It was reported that a patient developed decubitus on the chin while a (b)(4) - maquet gel pad was in use. The patient was under anaesthesia and in a prone position. Manufacturer reference # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010652-2019-00005 |
| MDR Report Key | 8331826 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-02-12 |
| Date of Report | 2019-09-25 |
| Date of Event | 2019-02-07 |
| Date Mfgr Received | 2019-08-30 |
| Date Added to Maude | 2019-02-12 |
| 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 | PRONE HEADREST |
| Generic Name | SURGICAL TABLE CUSHION |
| Product Code | LWG |
| Date Received | 2019-02-12 |
| Model Number | 40061900 |
| Catalog Number | 40061900 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2019-02-12 |