MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-07 for WALLACH PAPETTE KIT 908006 manufactured by Coopersurgical Inc..
[42957210]
Hologic received notification from a customer in the us whose client used a wallach papette collection device (coopersurgical p/n 908006, hologic p/n 70101-001) where the bristle heads detached inside a patient requiring removal by practitioner. Subsequent devices which come in wrapped in (b)(6) bags, were used from this same lot number without any problem. Hologic was informed as a precaution, this lot would be removed to insure patient safety and be returned to hologic for replacement. The lot number was not known at the time of the report but would be provided to hologic at a later time. The wallach papette collection device is not manufactured by hologic. Hologic has notified the manufacturer coopersurgical inc. Of this incident. Hologic considers this a reportable even since it required medical intervention to prevent harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2016-00086 |
| MDR Report Key | 5554309 |
| Date Received | 2016-04-07 |
| Date of Report | 2016-04-07 |
| Date Mfgr Received | 2016-03-08 |
| Date Added to Maude | 2016-04-07 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS EVA MAXWELL |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | WALLACH PAPETTE KIT |
| Generic Name | WALLACH PAPETTE KIT |
| Product Code | HFE |
| Date Received | 2016-04-07 |
| Model Number | 908006 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 1. Other | 2016-04-07 |