MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-04-15 for MILTEX THERE WERE NO IDENTIFYING NUMBERS ON THE DEVICE; ONLY manufactured by Miltex Instrument Co..
[95307]
Nurse trimming tape holding an oral gastric tube in place cut ear of baby.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 163250 |
| MDR Report Key | 163250 |
| Date Received | 1998-04-15 |
| Date of Report | 1998-03-31 |
| Date of Event | 1998-02-19 |
| Date Facility Aware | 1998-02-19 |
| Report Date | 1998-03-31 |
| Date Reported to FDA | 1998-04-13 |
| Date Reported to Mfgr | 1998-04-13 |
| Date Added to Maude | 1998-04-21 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MILTEX |
| Generic Name | SHEARS |
| Product Code | HRR |
| Date Received | 1998-04-15 |
| Model Number | THERE WERE NO IDENTIFYING |
| Catalog Number | NUMBERS ON THE DEVICE; ONLY |
| Lot Number | IMPRINTED ON HANDLE. |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 158922 |
| Manufacturer | MILTEX INSTRUMENT CO. |
| Manufacturer Address | 6 OHIO DRIVE LAKE SUCCESS NY 11042 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-04-15 |