MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-02-21 for PAPETT 908006 manufactured by Coopersurgical, Inc..
[2555030]
Some bristles come off the brush and remained in the vagina. Physician had to remove the particles.
Patient Sequence No: 1, Text Type: D, B5
[9605217]
The papette was not returned to coopersurgical for evaluation. A query of our complaint database revealed no similar complaints or any type of product trend. Should this product be returned to coopersurgical at a later date, we will provide a device evaluation follow up to fda. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1216677-2012-00003 |
| MDR Report Key | 2478559 |
| Report Source | 05 |
| Date Received | 2012-02-21 |
| Date of Report | 2012-02-14 |
| Date of Event | 2012-01-26 |
| Date Mfgr Received | 2012-01-26 |
| Date Added to Maude | 2012-08-22 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | THOMAS WILLAIMS |
| 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 | PAPETT |
| Generic Name | NONE |
| Product Code | HFE |
| Date Received | 2012-02-21 |
| Catalog Number | 908006 |
| Lot Number | 95589 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2012-02-21 |