MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-23 for STARMED ULTRA NITRILE GLOVES SMTN253 manufactured by Sempermed Usa, Inc..
[142736820]
Gloves are ripping/ tearing when pulled from box. 2 boxes of defective gloves removed from service. Manufacturer response for ultra nitrile gloves, starmed ultra nitrile gloves size medium (per site reporter). Sales representative for sempermed contacted regarding equipment failure. Defective gloves same ref# and lot # from previous visit have been submitted to manufacturer for evaluation. Thus, no need to send additional samples or boxes of gloves.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8539287 |
| MDR Report Key | 8539287 |
| Date Received | 2019-04-23 |
| Date of Report | 2019-04-22 |
| Date of Event | 2019-03-01 |
| Report Date | 2019-04-22 |
| Date Reported to FDA | 2019-04-22 |
| Date Reported to Mfgr | 2019-04-23 |
| Date Added to Maude | 2019-04-23 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 ULTRA NITRILE GLOVES |
| Generic Name | SURGEON'S GLOVES |
| Product Code | KGO |
| Date Received | 2019-04-23 |
| Catalog Number | SMTN253 |
| Lot Number | L025193 1804 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SEMPERMED USA, INC. |
| Manufacturer Address | 13900 49TH STREET NORTH CLEARWATER FL 33762 US 33762 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-23 |