MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-09-23 for COMFORT-FLEX 64-376 manufactured by Coopersurgical, Inc..
[1239728]
During a cervical dilatation, the tip of the dilator broke off in the patient. The broken tip was removed from the patient manually (fingers or forceps).
Patient Sequence No: 1, Text Type: D, B5
[8285410]
One of three dilators comprising the set was returned. The tip was broke off. The dilator had an orange residue and a yellow stain on the tip. The user facility indicated using dawn dish soap to clean the dilator. The dilator came in contact with betadine (iodine). The orange residue might be considered an indication the dilator was not cleaned properly, i. E. A soft bristle brush was not used to remove difficult matter. The residual betadine may have interacted with the teflon material of the dilator causing brittleness. A review of the complaint database did not reveal any similarly reported complaints. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1216677-2009-00027 |
| MDR Report Key | 1504985 |
| Report Source | 07 |
| Date Received | 2009-09-23 |
| Date of Report | 2009-09-22 |
| Date of Event | 2009-08-27 |
| Date Mfgr Received | 2009-09-14 |
| Date Added to Maude | 2010-06-25 |
| 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 | 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMFORT-FLEX |
| Generic Name | DILATOR SET |
| Product Code | HDQ |
| Date Received | 2009-09-23 |
| Model Number | 64-376 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | TRUMBULL CT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-09-23 |