MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06 report with the FDA on 2013-04-17 for PILLING GYN CURRETTE UNK manufactured by .
[3417682]
The event is reported as: complaint received via medwatch from fda. During a d and c surgery, it was noticed the device was missing the looped end when pulled out of the uterus. Xray was performed and the looped end was not in the uterus. It was found later in a plastic garbage bag by the circulating nurse. No reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
[10762190]
No sample is available for the manufacturer to evaluate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1044475-2013-00048 |
| MDR Report Key | 3109775 |
| Report Source | 00,05,06 |
| Date Received | 2013-04-17 |
| Date of Report | 2013-03-25 |
| Date of Event | 2013-03-11 |
| Date Mfgr Received | 2013-03-25 |
| Date Added to Maude | 2013-05-24 |
| 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 | ELAINE BURKLE, RN |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334957 |
| Manufacturer G1 | TELEFLEX |
| Manufacturer Street | 2917 WECK DR. |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PILLING GYN CURRETTE |
| Generic Name | CURRETTE |
| Product Code | HCY |
| Date Received | 2013-04-17 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-17 |