MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-12 for SENSICARE ICE MDS6801 manufactured by Medline Industries.
[94502655]
Patient Sequence No: 1, Text Type: N, H10
[94502656]
While donning nitrile exam gloves, the clinicians noticed some type of material in the gloves. Upon inspection of the glove, the clinician removed a foreign object from the glove. The glove and object were retrieved and sent to biomedical, along with the original glove container to be sent to the manufacturer for analysis and reporting. The clinician ordered a new box of exam gloves. No apparent patient harm from this event. Manufacturer response for gloves, exam, nitrile, sensicare ice (per site reporter). Awaiting follow-up from manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7107654 |
| MDR Report Key | 7107654 |
| Date Received | 2017-12-12 |
| Date of Report | 2017-12-02 |
| Date of Event | 2017-11-23 |
| Report Date | 2017-12-02 |
| Date Reported to FDA | 2017-12-02 |
| Date Reported to Mfgr | 2017-12-02 |
| Date Added to Maude | 2017-12-12 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SENSICARE ICE |
| Generic Name | VINYL PATIENT EXAMINATION GLOVE |
| Product Code | LYZ |
| Date Received | 2017-12-12 |
| Model Number | MDS6801 |
| Catalog Number | MDS6801 |
| Lot Number | AN709540946 |
| ID Number | SENSICARE ICE BLUE NITRILE EX |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES |
| Manufacturer Address | LARA SIMMONS ONE MEDLINE PL. MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-12 |