MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-05 for HYSTEROSCOPE 72205001 manufactured by W.o.m World Of Medicine Gmbh.
[178262355]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[178262356]
According to the reporter, during servicing at the facility, the scale test was not within the normal limits. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[188937600]
This event has been reassessed and found not to be a reportable event and is not associated with a serious injury or potential for serious injury with reoccurrence. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2020-00118 |
| MDR Report Key | 9673403 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-11 |
| Date of Event | 2020-01-23 |
| Date Mfgr Received | 2020-01-23 |
| Date Added to Maude | 2020-02-05 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LISA HERNANDEZ |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 2034925563 |
| Manufacturer G1 | W.O.M WORLD OF MEDICINE GMBH |
| Manufacturer Street | ALTE PSTSTRABE, 11 - 96337 |
| Manufacturer City | LUDWIGSSTADT 96337 |
| Manufacturer Postal Code | 96337 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYSTEROSCOPE |
| Generic Name | HYSTEROSCOPE (AND ACCESSORIES) |
| Product Code | HIH |
| Date Received | 2020-02-05 |
| Model Number | 72205001 |
| Catalog Number | 72205001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | W.O.M WORLD OF MEDICINE GMBH |
| Manufacturer Address | ALTE PSTSTRABE, 11 - 96337 LUDWIGSSTADT 96337 96337 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-05 |