MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-18 for STARMED SMTN254 manufactured by Sempermed Usa, Inc..
[80296023]
Patient Sequence No: 1, Text Type: N, H10
[80296024]
Starmed ultra nitrile large gloves noted to have thin spots/small holes throughout when placed on hand. Entire box removed from staff use. Manufacturer response for ultra nitrile gloves, starmed ultra nitrile (per site reporter): quality event report will be send to sempermed and will await where to send the defective product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6721216 |
| MDR Report Key | 6721216 |
| Date Received | 2017-07-18 |
| Date of Report | 2017-06-27 |
| Date of Event | 2017-05-15 |
| Report Date | 2017-06-15 |
| Date Reported to FDA | 2017-06-15 |
| Date Reported to Mfgr | 2017-06-15 |
| Date Added to Maude | 2017-07-18 |
| 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 |
| 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 | STARMED |
| Generic Name | non-powdered polymer patient examination glove |
| Product Code | LZA |
| Date Received | 2017-07-18 |
| Catalog Number | SMTN254 |
| Lot Number | 0500 0335 |
| Operator | NURSE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SEMPERMED USA, INC. |
| Manufacturer Address | 13900 49TH ST. NORTH CLEARWATER FL 33762 US 33762 |
| Brand Name | STARMED |
| Generic Name | SURGEON'S GLOVES |
| Product Code | KGO |
| Date Received | 2017-07-18 |
| Catalog Number | SMTN254 |
| Lot Number | 0500 0335 |
| Operator | NURSE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SEMPERMED USA, INC. |
| Manufacturer Address | 13900 49TH ST. NORTH CLEARWATER FL 33762 US 33762 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-18 |