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 |