MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2000-05-16 for manufactured by .
| Report Number | 2647856-2000-00017 |
| MDR Report Key | 278161 |
| Report Source | 05,06 |
| Date Received | 2000-05-16 |
| Date of Event | 2000-02-24 |
| Date Mfgr Received | 2000-04-14 |
| Date Added to Maude | 2000-05-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | PETER APRILE, R.PH |
| Manufacturer Street | 717 MAIN ST |
| Manufacturer City | WESTBURY NY 11590 |
| Manufacturer Country | US |
| Manufacturer Postal | 11590 |
| Manufacturer Phone | 8005444624 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | FGD |
| Date Received | 2000-05-16 |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 269245 |
| Baseline Brand Name | FLEXI-CUFF RETENTION TIP |
| Baseline Generic Name | NON LATEX ENEMA TIP |
| Baseline Model No | NA |
| Baseline Catalog No | 8816 |
| Baseline ID | NA |
| Baseline Device Family | FLEXI-TIP ENEMA TIP SERIES |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K905574 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-05-16 |