MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-09-08 for SPIEGELBERG INS01.001.01 manufactured by Spiegelberg Gmbh & Co. Kg.
[54750911]
This mdr is being filed retrospectively.
Patient Sequence No: 1, Text Type: N, H10
[54750912]
The irrigation was not working even at the lowest suction level. Irrigation was immediately being sucked back into the system. The irrigation would not work unless the button was depressed the whole time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002108226-2016-00012 |
| MDR Report Key | 5936242 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-09-08 |
| Date of Report | 2016-03-18 |
| Date of Event | 2014-10-02 |
| Date Mfgr Received | 2014-12-17 |
| Date Added to Maude | 2016-09-08 |
| 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 | 40 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 | 0 |
| Brand Name | SPIEGELBERG |
| Generic Name | STIEGLITZ SUCTION AND IRRIGATION DEVICE |
| Product Code | GZX |
| Date Received | 2016-09-08 |
| Model Number | INS01.001.01 |
| Catalog Number | INS01.001.01 |
| Lot Number | 3421002314 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-09-08 |