MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-12 for SENSICARE SURGICAL GLOVE manufactured by Medline.
[89374593]
Medline size 7 sensicare gloves lot 706938579770-7, exp 05/2020, and medline size 7-1/2 sensicare surgical gloves lot: 705938579775-3, exp 04/2020, have black particles embedded within the gloves. Reason for use: for compounding.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072723 |
| MDR Report Key | 6943835 |
| Date Received | 2017-10-12 |
| Date of Report | 2017-10-10 |
| Date of Event | 2017-10-09 |
| Date Added to Maude | 2017-10-12 |
| 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 SURGICAL GLOVE |
| Generic Name | SENSICARE SURGICAL GLOVE |
| Product Code | LYZ |
| Date Received | 2017-10-12 |
| Lot Number | 706938579770-7 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE |
| Brand Name | SENSICARE SURGICAL GLOVE |
| Generic Name | SENSICARE SURGICAL GLOVE |
| Product Code | LYZ |
| Date Received | 2017-10-12 |
| Lot Number | 705938579775-3 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-12 |