MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-18 for DEFINITY CERVICAL DILATOR DCD-701 manufactured by Hologic, Inc.
[183976081]
Device history record (dhr) review was conducted for the reported identification number. The lot was released meeting all qa specifications. The device is not being returned therefore, a failure analysis of the complaint device cannot be completed. If additional relevant information is received or device evaluation completed, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[183976082]
It was reported that the physician was using the device on a patient which he created a false passage on two weeks prior. The device was inserted and then the patient cervix was dilated. Once the scope was inserted, a perforation was identified. No additional details available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2020-00059 |
| MDR Report Key | 9849776 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-18 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2020-01-16 |
| Date Added to Maude | 2020-03-18 |
| 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 | KELSEA LYVER |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH, MA |
| Manufacturer Country | US |
| Manufacturer Phone | 2636130 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEFINITY CERVICAL DILATOR |
| Generic Name | CERVICAL DILATOR |
| Product Code | PON |
| Date Received | 2020-03-18 |
| Model Number | DCD-701 |
| Catalog Number | DCD-701 |
| Lot Number | 20A16RC |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC |
| Manufacturer Address | 250 CAMPUS DRIVE MARLBOROUGH, MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-18 |