MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-17 for GRHS D & C VAG HYST CUSTOM PACK GIDC79C manufactured by American Contract Systems.
[145542270]
Hair found in raytec sponge. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086718 |
| MDR Report Key | 8623714 |
| Date Received | 2019-05-17 |
| Date of Report | 2019-05-16 |
| Date of Event | 2019-03-20 |
| Date Added to Maude | 2019-05-20 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | GRHS D & C VAG HYST CUSTOM PACK |
| Generic Name | GYNECOLOGICAL LAPAROSCOPIC KIT |
| Product Code | OHD |
| Date Received | 2019-05-17 |
| Catalog Number | GIDC79C |
| Lot Number | 983191 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN CONTRACT SYSTEMS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-17 |