MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-21 for HANK DILATORS 9/10 -19/20 AMERICAN SCALE MD070R manufactured by Contract Manufacturer: Merced Medical.
[103280960]
Manufacturing site evaluation: evaluation on-going
Patient Sequence No: 1, Text Type: N, H10
[103280961]
Country of complaint: usa insertion of product in to anatomy and almost caused perforation because the rings do not line up correctly, no harm to the patient reported. 15 minuted delay in surgery reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2018-00007 |
| MDR Report Key | 7359682 |
| Date Received | 2018-03-21 |
| Date of Report | 2018-04-24 |
| Date of Event | 2018-02-21 |
| Date Facility Aware | 2018-02-26 |
| Date Mfgr Received | 2018-02-21 |
| Date Added to Maude | 2018-03-21 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | CONTRACT MANUFACTURER: MERCED MEDICAL |
| Manufacturer Street | 1019 WEST WISE ROAD SUITE 201 |
| Manufacturer City | SCHAUMBURG IL 60193 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60193 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HANK DILATORS 9/10 -19/20 AMERICAN SCALE |
| Generic Name | GENERAL SURGICAL INSTRUMENTS |
| Product Code | HDQ |
| Date Received | 2018-03-21 |
| Model Number | MD070R |
| Catalog Number | MD070R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONTRACT MANUFACTURER: MERCED MEDICAL |
| Manufacturer Address | 1019 WEST WISE ROAD SUITE 201 SCHAUMBURG IL 60193 US 60193 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-21 |