MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-03-13 for CIRCON ACMI ETOR-24 TIMBERLAKE OBTURATOR * manufactured by Circon Acmi.
[21712822]
Loose pin in obturator tip, protruding, and caused laceration of urethra. Prognosis (long term) unk at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1013210 |
| MDR Report Key | 157645 |
| Date Received | 1998-03-13 |
| Date of Report | 1998-03-10 |
| Date of Event | 1998-03-09 |
| Date Added to Maude | 1998-03-20 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CIRCON ACMI |
| Generic Name | CYST OBTURATOR |
| Product Code | FEC |
| Date Received | 1998-03-13 |
| Returned To Mfg | 1998-03-10 |
| Model Number | ETOR-24 TIMBERLAKE OBTURATOR |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 153593 |
| Manufacturer | CIRCON ACMI |
| Manufacturer Address | 300 STILLWATER AVE. STAMFORD CT 069041971 US |
| Baseline Brand Name | TIMBERLAKE OBTURATOR |
| Baseline Generic Name | OBTURATOR |
| Baseline Model No | ETOR-24 |
| Baseline Catalog No | ETOR-24 |
| Baseline ID | NA |
| Baseline Device Family | OBTURATOR |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-03-13 |