MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-11 for BIOGEL SURGEONS GLOVE 30470 manufactured by Molnlycke Healthcare.
[94396199]
Patient Sequence No: 1, Text Type: N, H10
[94396200]
Latex biogel gloves were opened onto the sterile field in the appropriate sterile fashion, when the gloves were opened by the surgeon, a hair was noticed to be insided of the glove. The gloves were immediately passed off the field and replaced.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 7103853 |
MDR Report Key | 7103853 |
Date Received | 2017-12-11 |
Date of Report | 2017-12-06 |
Date of Event | 2017-12-04 |
Report Date | 2017-12-06 |
Date Reported to FDA | 2017-12-06 |
Date Reported to Mfgr | 2017-12-06 |
Date Added to Maude | 2017-12-11 |
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 |
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 | BIOGEL SURGEONS GLOVE |
Generic Name | SURGEON'S GLOVES |
Product Code | FMC |
Date Received | 2017-12-11 |
Model Number | 30470 |
Catalog Number | 30470 |
Lot Number | 17G621 |
Device Availability | Y |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | MOLNLYCKE HEALTHCARE |
Manufacturer Address | 5550 PEACHTREE PARKWAY SUITE 500 NORCROSS GA 30092 US 30092 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2017-12-11 |