MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2005-02-25 for ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL 173050G manufactured by Ponce - Uss.
[344863]
The device was used during a cholecystectomy. The bag broke as the specimen was placed inside. The surgeon was able to retrieve the bag and the specimen without injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2647580-2005-00101 |
| MDR Report Key | 579180 |
| Report Source | 06,07 |
| Date Received | 2005-02-25 |
| Date of Report | 2005-01-25 |
| Date of Event | 2005-01-11 |
| Date Mfgr Received | 2005-01-25 |
| Device Manufacturer Date | 2004-10-01 |
| Date Added to Maude | 2005-03-09 |
| 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 Contact | JEFF DEMING |
| Manufacturer Street | 195 MCDERMOTT RD. |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034926049 |
| Manufacturer G1 | PONCE - USS |
| Manufacturer Street | SABANETAS INDUSTRIAL PARK |
| Manufacturer City | MERCEDITA PR 00715 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00715 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL |
| Generic Name | DISPOSABLE SPECIMEN RETRIEVAL DEVICE |
| Product Code | KDW |
| Date Received | 2005-02-25 |
| Model Number | NA |
| Catalog Number | 173050G |
| Lot Number | P4K677 |
| ID Number | NA |
| Device Expiration Date | 2009-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 569031 |
| Manufacturer | PONCE - USS |
| Manufacturer Address | SABANETAS INDUSTRIAL PARK MERCEDITA PR 00715 US |
| Baseline Brand Name | ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL |
| Baseline Generic Name | DISPOSABLE SPECIMEN RETRIEVAL SYSTEM |
| Baseline Model No | NA |
| Baseline Catalog No | 173050G |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-02-25 |