MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2020-02-27 for SLINGS, CLIP MAA4000-M manufactured by Arjo Dominican Republic.
| Report Number | 3012292104-2020-00002 |
| MDR Report Key | 9762408 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2020-02-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-01-17 |
| Date Mfgr Received | 2020-02-18 |
| Date Added to Maude | 2020-02-27 |
| 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 | KINGA STOLINSKA |
| Manufacturer Street | KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI 62-052 |
| Manufacturer Country | PL |
| Manufacturer Postal | 62-052 |
| Manufacturer Phone | 688282467 |
| Manufacturer G1 | ARJO DOMINICAN REPUBLIC |
| Manufacturer Street | BUILDING 9 PIISA INDUSTRIAL PA KM18 1/2 ANTIGUA CARRETERA S |
| Manufacturer City | ITABO 10903 |
| Manufacturer Country | DR |
| Manufacturer Postal Code | 10903 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SLINGS, CLIP |
| Generic Name | LIFT, PATIENT, NON-AC-POWERED |
| Product Code | FSA |
| Date Received | 2020-02-27 |
| Model Number | MAA4000-M |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJO DOMINICAN REPUBLIC |
| Manufacturer Address | BUILDING 9 PIISA INDUSTRIAL PA KM18 1/2 ANTIGUA CARRETERA S ITABO 10903 DR 10903 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-27 |