MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-05-23 for MEDLINE MDS 194035 manufactured by Medline Industries Inc.
[2002479]
A (b)(6) male patient with traumatic injuries from a work place fall was admitted to (b)(6) from (b)(6) 2011. The patient had multiple fractures including the 1st through 10th rib on the right side. The patient also developed a pneumothorax of his right lung which was relieved with short term chest tube insertion on (b)(6) 2011. On (b)(6) 2011, the patient was readmitted to (b)(6) with increased shortness of breath, recurrence of the right lung pneumothorax with evidence of an infection. A chest tube was inserted by interventional radiology. The patient's status did not improve and a right thoracotomy was performed on (b)(6) 2011. A foreign body of a portion of a latex surgical glove was found in the lung cavity close to the original chest tube insertion site. This was removed without incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5020745 |
| MDR Report Key | 2108123 |
| Date Received | 2011-05-23 |
| Date of Report | 2011-05-23 |
| Date of Event | 2011-02-27 |
| Date Added to Maude | 2011-06-02 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDLINE |
| Generic Name | POWDER-FREE LATEX EXAM GLOVES |
| Product Code | LYY |
| Date Received | 2011-05-23 |
| Model Number | MDS 194035 |
| Lot Number | PAN004914345 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC |
| Manufacturer Address | MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Deathisabilit | 2011-05-23 |