MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-24 for SENSICARE GLOVES MSG1070 manufactured by Medline.
[73901065]
Technician opened a pair of medline sensicare sterile gloves, size 7 (lot# 612893046370, ref/item# (b)(4)) to discover some brownish spotting on the gloves. Medline contacted, quality complaint #(b)(4) assigned. Affected gloves to be returned to medline for analysis. Pulled that lot# out of circulation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069352 |
| MDR Report Key | 6522256 |
| Date Received | 2017-04-24 |
| Date of Report | 2017-04-24 |
| Date of Event | 2017-04-17 |
| Date Added to Maude | 2017-04-26 |
| 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 | PHARMACIST |
| 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 | 0 |
| Brand Name | SENSICARE GLOVES |
| Generic Name | SENSICARE GLOVES |
| Product Code | LYY |
| Date Received | 2017-04-24 |
| Catalog Number | MSG1070 |
| Lot Number | 612893046370 |
| Device Expiration Date | 2019-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-24 |