MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-08-14 for WALLACH PAPETTE CERVICAL CELL SAMPLER 908003 manufactured by Wallach Surgical Devices, Inc..
[8086605]
No other complaints have been reported for papettes of this lot # from this or any other source. Papettes are supplied in 25 count bags. Only one sample from the lot that the physician returned and had identified showed signs of damage. The damage is not consistent with deficiencies known to occur during the manufacture of the product. However, it is not concluded that this damage is a contributing factor. Handling and storage conditions cannot be determined at this time. The one identified papette was pull tested for strength of separation. A low separation strength was found, which is consistent with that of a brush that has been removed and reassembled on its handle. The incident was a rare occurrence out of 16 million papette sold in one year. No further action/corrective action required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219739-2007-00003 |
| MDR Report Key | 981156 |
| Report Source | 06 |
| Date Received | 2007-08-14 |
| Date Mfgr Received | 2007-08-02 |
| Device Manufacturer Date | 2005-12-01 |
| Date Added to Maude | 2008-01-18 |
| 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 | 0 |
| Manufacturer Street | 235 EDISON RD. |
| Manufacturer City | ORANGE CT 06477 |
| Manufacturer Country | US |
| Manufacturer Postal | 06477 |
| Manufacturer Phone | 2037992000 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WALLACH PAPETTE CERVICAL CELL SAMPLER |
| Generic Name | PAP SMEAR BRUSH |
| Product Code | HHT |
| Date Received | 2007-08-14 |
| Model Number | NA |
| Catalog Number | 908003 |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 948647 |
| Manufacturer | WALLACH SURGICAL DEVICES, INC. |
| Manufacturer Address | 235 EDISON RD. ORANGE CT 06477 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-08-14 |