MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-05-17 for STIEGLITZ SUCTION AND IRRIGATION DEVICE INS01.001.01 manufactured by Spiegelberg Gmbh & Co. Kg.
[75346738]
The push button of four stieglitz suction and irrigation devices stuck during an application. Afterwards, the devices could no longer be used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002108226-2017-00003 |
| MDR Report Key | 6572160 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-05-17 |
| Date of Report | 2017-03-13 |
| Date of Event | 2016-02-27 |
| Date Mfgr Received | 2016-02-29 |
| Date Added to Maude | 2017-05-17 |
| 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 Contact | MR. LEONHARD BLAUROCK |
| Manufacturer Street | TEMPOWERKRING 4 |
| Manufacturer City | HAMBURG, 21079 |
| Manufacturer Country | GM |
| Manufacturer Postal | 21079 |
| Manufacturer Phone | 0 7901780 |
| Manufacturer G1 | SPIEGELBERG GMBH & CO. KG |
| Manufacturer Street | TEMPOWERKRING 4 |
| Manufacturer City | HAMBURG, 21079 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 21079 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STIEGLITZ SUCTION AND IRRIGATION DEVICE |
| Generic Name | STIEGLITZ SUCTION AND IRRIGATION DEVICE |
| Product Code | GZX |
| Date Received | 2017-05-17 |
| Model Number | INS01.001.01 |
| Catalog Number | INS01.001.01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPIEGELBERG GMBH & CO. KG |
| Manufacturer Address | TEMPOWERKRING 4 HAMBURG, 21079 GM 21079 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-17 |