MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-29 for PAPETTE,500 PER BOX,CYTYC 908006 manufactured by Coopersurgical, Inc..
[61297045]
Coopersurgical inc. Is currently investigating the reported complaint condition. The device involved in the complaint has not been returned by the customer for evaluation. Once the investigation is completed a follow-up report will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[61297046]
Per medwatch uf importer report number (b)(4). "event desc: the cytobrush used to collect pap smear separated upon withdrawal from female patient. The cytobrush portion was then retrieved from the vagina using a sterile ob instrument. There was slight bleeding seen in post vaginal wall and patient was advised she may have spotting. " (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2016-00069 |
| MDR Report Key | 6131894 |
| Date Received | 2016-11-29 |
| Date of Report | 2016-09-24 |
| Date of Event | 2016-08-26 |
| Date Mfgr Received | 2016-09-06 |
| Device Manufacturer Date | 2015-05-28 |
| Date Added to Maude | 2016-11-29 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. NANA BANAFO |
| Manufacturer Street | 75 CORPORATE DRIVE |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Manufacturer Phone | 2036015200 |
| Manufacturer G1 | COOPERSURGICAL, INC. |
| Manufacturer Street | 75 CORPORATE DRIVE |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06611 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PAPETTE,500 PER BOX,CYTYC |
| Generic Name | PAPETTE,500 PER BOX,CYTYC |
| Product Code | OHL |
| Date Received | 2016-11-29 |
| Model Number | 908006 |
| Catalog Number | 908006 |
| Lot Number | 166045 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | 75 CORPORATE DRIVE TRUMBULL CT 06611 US 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-29 |