MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2000-11-07 for PILLING 52-2301 manufactured by Pilling Surgical.
[199447]
Mediastinoscope was introduced and dissection continued - it became evident that there was a tear in the anterior aspect of the trachea at the limit of mediastinoscope required thorocotomy to repair.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1055934-2000-00001 |
| MDR Report Key | 306386 |
| Report Source | 07 |
| Date Received | 2000-11-07 |
| Date of Report | 2000-08-24 |
| Date of Event | 2000-08-02 |
| Date Facility Aware | 2000-08-08 |
| Report Date | 2000-08-24 |
| Date Reported to Mfgr | 2000-08-24 |
| Date Mfgr Received | 2000-09-07 |
| Device Manufacturer Date | 1996-06-01 |
| Date Added to Maude | 2000-11-30 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ELIZABETH LAZARO |
| Manufacturer Street | 420 DELAWARE DR |
| Manufacturer City | FT. WASHINGTON PA 19034 |
| Manufacturer Country | US |
| Manufacturer Postal | 19034 |
| Manufacturer Phone | 2156432600 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PILLING |
| Generic Name | MEDIASTINOSCOPE |
| Product Code | EWY |
| Date Received | 2000-11-07 |
| Model Number | 52-2301 |
| Catalog Number | 52-2301 |
| Lot Number | NA |
| ID Number | FF6 DATE CODE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 296508 |
| Manufacturer | PILLING SURGICAL |
| Manufacturer Address | 420 DELAWARE DR FT. WASHINGTON PA 19034 US |
| Baseline Brand Name | PILLING |
| Baseline Generic Name | MEDIASTINOSCOPE |
| Baseline Model No | 52-2301 |
| Baseline Catalog No | 52-2301 |
| Baseline ID | FF6 DATE CODE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-11-07 |