MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2011-07-25 for LATEX EXAM GLOVE, STERILE MDS194035 manufactured by Medline Industries, Inc..
[17095849]
A pt developed complications one month following a chest tube insertion. A thoracotomy was performed and a finger from a latex glove was found and removed without further incident.
Patient Sequence No: 1, Text Type: D, B5
[17179211]
A pt was admitted to the hospital for multiple traumatic injuries including fractures of his 1st through 10th ribs on his right side. A pneumothorax developed and a chest tube was inserted on (b)(6) 2011. A month later, he developed complications including shortness of breath, recurrence of the pneumothorax and evidence of an infection. Another chest tube was inserted without improvement. The pt underwent a thoracotomy on (b)(6) 2011 at which time the finger of a latex glove was found in close proximity to the original chest tube insertion site. It was removed without incident. No other complications were reported. There were no complications or issues reported at the time of the initial chest tube insertion. It is not known why the torn and missing finger of the glove was not identified at the time of the original chest tube insertion. No corrective action to be taken at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2011-00041 |
| MDR Report Key | 2194551 |
| Report Source | 00,06 |
| Date Received | 2011-07-25 |
| Date of Report | 2011-07-18 |
| Date of Event | 2011-02-27 |
| Date Mfgr Received | 2011-06-30 |
| Device Manufacturer Date | 2010-11-01 |
| Date Added to Maude | 2011-08-11 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JULIE FINLEY |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LATEX EXAM GLOVE, STERILE |
| Generic Name | NONE |
| Product Code | LYY |
| Date Received | 2011-07-25 |
| Model Number | MDS194035 |
| Lot Number | PAN004914345 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | MUNDELEIN IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-07-25 |