MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-08-01 for BIOGEL SKINSENSE 31465 manufactured by Molnlycke.
| Report Number | 3004763499-2019-00007 |
| MDR Report Key | 8851171 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-08-01 |
| Date of Report | 2019-07-02 |
| Date of Event | 2019-06-27 |
| Date Mfgr Received | 2019-07-02 |
| Device Manufacturer Date | 2018-12-22 |
| Date Added to Maude | 2019-08-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 |
| Manufacturer Contact | MS PAT STRAHL |
| Manufacturer Street | 5550 PEACHTREE PARKWAY SUITE 500 |
| Manufacturer City | NORCROSS GA 30092 |
| Manufacturer Country | US |
| Manufacturer Postal | 30092 |
| Manufacturer Phone | 4703750171 |
| Manufacturer G1 | MOLNLYCKE |
| Manufacturer Street | 5550 PEACHTREE PARKWAY SUITE 500 |
| Manufacturer City | NORCROSS GA 30092 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30092 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOGEL SKINSENSE |
| Generic Name | SURGEON'S GLOVES |
| Product Code | KGO |
| Date Received | 2019-08-01 |
| Returned To Mfg | 2019-07-29 |
| Model Number | 31465 |
| Lot Number | (10)18L468 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MOLNLYCKE |
| Manufacturer Address | 5550 PEACHTREE PARKWAY SUITE 500 NORCROSS GA 30092 US 30092 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-08-01 |