MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-04 for BARDEX? MALECOT MODEL DRAIN 086032 manufactured by C. R. Bard, Inc..
[93584832]
Patient Sequence No: 1, Text Type: N, H10
[93584833]
Rectal tube inserted on admission (non-ballooned) and replaced during admission. Needed as was unable to have nasogastric tube related to epistaxis. Rectal tube needed for lactulose administration. Patient suffered lower rectal bleed from a rectal ulcer requiring clipping.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7078471 |
| MDR Report Key | 7078471 |
| Date Received | 2017-12-04 |
| Date of Report | 2017-12-01 |
| Date of Event | 2016-11-06 |
| Report Date | 2017-11-22 |
| Date Reported to FDA | 2017-11-22 |
| Date Reported to Mfgr | 2017-11-22 |
| Date Added to Maude | 2017-12-04 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Brand Name | BARDEX? MALECOT MODEL DRAIN |
| Generic Name | CATHETER, MALECOT |
| Product Code | FEW |
| Date Received | 2017-12-04 |
| Model Number | 086032 |
| Catalog Number | 086032 |
| Lot Number | NGBP2484 |
| Device Availability | N |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C. R. BARD, INC. |
| Manufacturer Address | 1211 MARY MAGNAN BLVD. MADISON GA 30650 US 30650 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-04 |