MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-11 for GARRET DILATOR 1.0MM 5570-03 LP-030416 manufactured by Unk.
[113930818]
Pediatric liver transplant utilized a dilator for the first time use and the tip broke off in liver. Instrument info: garret dilator 1. 0mm 5570-03 lp-030416, unable to retrieve tip and pt monitored.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078347 |
| MDR Report Key | 7681313 |
| Date Received | 2018-07-11 |
| Date of Report | 2018-07-10 |
| Date Added to Maude | 2018-07-12 |
| 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 | GARRET DILATOR 1.0MM 5570-03 LP-030416 |
| Generic Name | GARRET DILATOR 1.0MM 5570-03 LP-030416 |
| Product Code | FFP |
| Date Received | 2018-07-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-07-11 |