MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-05 for FLEXIMA ALL PURPOSE DRNG LOOP CATHETER M001271380 manufactured by Boston Scientific Corporation.
[126496815]
Tube separated near valve in an area uncommon for tube/catheter to separate.
Patient Sequence No: 0, Text Type: D, B5
| Report Number | MW5081074 |
| MDR Report Key | 8042236 |
| Date Received | 2018-11-05 |
| Date of Report | 2018-10-31 |
| Date of Event | 2018-10-22 |
| Date Added to Maude | 2018-11-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FLEXIMA ALL PURPOSE DRNG LOOP CATHETER |
| Generic Name | TUBE, DRAINAGE, SUPRAPUBIC |
| Product Code | FFA |
| Date Received | 2018-11-05 |
| Catalog Number | M001271380 |
| Lot Number | 21091453 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | MARLBOROUGH MA 01752 US 01752 |
| Brand Name | FLEXIMA ALL PURPOSE DRNG LOOP CATHETER |
| Generic Name | CHEST TUBE/CATHETER, NEPHROSTOMY, GENERAL AND PLASTIC SURGERY |
| Product Code | GBO |
| Date Received | 2018-11-05 |
| Catalog Number | M001271380 |
| Lot Number | 21091453 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-11-05 |