MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2007-11-14 for KOH CUP manufactured by Coopersurgical, Inc..
[753954]
Following an lsh, a patient was found to have the koh cup still in the vagina.
Patient Sequence No: 1, Text Type: D, B5
[7947075]
Some time in 2007, the patient had a hysterectomy at a different facility performed by a different physician than the initial reporter. The patient was advised by the initial reporter the koh cup was left in the vagina. The initial reporter removed the koh cup surgically.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1216677-2007-00030 |
| MDR Report Key | 975596 |
| Report Source | 99 |
| Date Received | 2007-11-14 |
| Date of Report | 2007-11-14 |
| Date Mfgr Received | 2007-10-16 |
| Date Added to Maude | 2008-05-27 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | THOMAS WILLIAMS |
| Manufacturer Street | 95 CORPORATE DR. |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Manufacturer Phone | 2036015200 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KOH CUP |
| Generic Name | COLPOTOMIZER SYSTEM |
| Product Code | HDM |
| Date Received | 2007-11-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 979102 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | TRUMBULL CT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-11-14 |