MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-19 for SURGICAL GLOVE BIOGEL SURGEONS SIZE 30485 manufactured by Molnlycke Health Care Us Llc.
[184077267]
Molnlycke biogel surgeons natural rubber latex surgical gloves, size 8 1/2, ref 30485, exp 08/28/2022, lot 191671 - opened outer package and long dark hair seen within the package. Packaging and hair saved; no patient exposure; no contamination of field.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9853247 |
| MDR Report Key | 9853247 |
| Date Received | 2020-03-19 |
| Date of Report | 2020-02-13 |
| Date of Event | 2020-01-13 |
| Report Date | 2020-02-13 |
| Date Reported to FDA | 2020-02-13 |
| Date Reported to Mfgr | 2020-03-19 |
| Date Added to Maude | 2020-03-19 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 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 | SURGICAL GLOVE BIOGEL SURGEONS SIZE |
| Generic Name | SURGEON'S GLOVES |
| Product Code | KGO |
| Date Received | 2020-03-19 |
| Model Number | 30485 |
| Catalog Number | 30485 |
| Lot Number | 191671 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MOLNLYCKE HEALTH CARE US LLC |
| Manufacturer Address | 5550 PEACHTREE PARKWAY, SUITE 500 NORCROSS GA 30092 US 30092 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-19 |