MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-10 for PLEURAFLOW SYSTEM UNK manufactured by Clearflow Inc.
[23864208]
Suture entrapment of chest tube resulted in a chest tube tear when it was pulled out & a portion of the chest tube remaining entrapped inside the chest. The original incision was re-opened & the portion of the chest tube was removed from the chest. Procedure was done in the operating room. There was no permanent damage to the patient. This was the result of an iatrogenic source.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008782989-2015-00001 |
| MDR Report Key | 4996438 |
| Date Received | 2015-08-10 |
| Date of Report | 2015-08-10 |
| Date of Event | 2015-07-13 |
| Date Mfgr Received | 2015-07-14 |
| Date Added to Maude | 2015-08-12 |
| 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 | 3 |
| Manufacturer Street | 1630 S SUNKIST ST STE E |
| Manufacturer City | ANAHEIM CA 92806 |
| Manufacturer Country | US |
| Manufacturer Postal | 92806 |
| Manufacturer G1 | CLEARFLOW INC |
| Manufacturer Street | 4700 S. OVERLAND DR. |
| Manufacturer City | TUCSON AZ 85714 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85714 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PLEURAFLOW SYSTEM |
| Product Code | OTK |
| Date Received | 2015-08-10 |
| Model Number | PLEURAFLOW SYSTEM |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLEARFLOW INC |
| Manufacturer Address | 1630 S SUNKIST ST STE E ANAHEIM CA 92806 US 92806 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2015-08-10 |