MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2006-05-10 for ORTHO MINOR PACK-LF DYNJV0161G * manufactured by Medline Industries, Inc..
[20192437]
Reportedly during a tonsillectomy the doctor was flushing out the nasal flair and a piece of plastic from a ear ulcer syringe got lodge in the nasal bed of the pt. The pt started bleeding in post op and required cauterization.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2006-00004 |
| MDR Report Key | 713433 |
| Report Source | 05,07 |
| Date Received | 2006-05-10 |
| Date of Report | 2006-05-10 |
| Date of Event | 2006-04-13 |
| Date Mfgr Received | 2006-04-13 |
| Date Added to Maude | 2006-05-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Manufacturer Contact | LARA SIMMONS |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8478372759 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHO MINOR PACK-LF |
| Generic Name | EAR ULCER SYRINGE IN ORTHO MINOR PACK |
| Product Code | KCP |
| Date Received | 2006-05-10 |
| Returned To Mfg | 2006-04-17 |
| Model Number | DYNJV0161G |
| Catalog Number | * |
| Lot Number | 06AB1184 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 702502 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | * MUNDELEIN IL * US |
| Baseline Brand Name | ORTHO MINOR PACK-LF |
| Baseline Generic Name | EAR ULCER SYRINGE IN ORTHO MINOR PACK |
| Baseline Model No | DYNJV0161G |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-05-10 |