MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07,08 report with the FDA on 2001-07-24 for VALTRAC BOWEL ANASTOMOTIC RING 28MM/1.5MM 8886808700 manufactured by United States Surgical Corp..
[15603865]
Reportedly, when the surgeon inserted the device into the intestine, it cracked. The anastomosis was hand sewed. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2647580-2001-00392 |
| MDR Report Key | 343913 |
| Report Source | 05,07,08 |
| Date Received | 2001-07-24 |
| Date of Report | 2001-06-25 |
| Date of Event | 2001-06-19 |
| Date Facility Aware | 2001-06-19 |
| Date Mfgr Received | 2001-06-25 |
| Device Manufacturer Date | 1998-09-01 |
| Date Added to Maude | 2001-07-30 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LAURA ROEPE, RN, MA |
| Manufacturer Street | 195 MCDERMOTT ROAD |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034926334 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VALTRAC BOWEL ANASTOMOTIC RING 28MM/1.5MM |
| Generic Name | ANASTOMOSIS RINGS |
| Product Code | LNN |
| Date Received | 2001-07-24 |
| Returned To Mfg | 2001-10-28 |
| Model Number | NA |
| Catalog Number | 8886808700 |
| Lot Number | 897467 |
| ID Number | NA |
| Device Expiration Date | 2003-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 33 MO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 333249 |
| Manufacturer | UNITED STATES SURGICAL CORP. |
| Manufacturer Address | SABANETAS INDUSTRIAL PARK MERCEDITA PR 00715 US |
| Baseline Brand Name | VALTRAC BOWEL ANASTOMOTIC RING 28MM/1.5MM |
| Baseline Generic Name | ANASTOMOSIS RINGS |
| Baseline Model No | NA |
| Baseline Catalog No | 8886808700 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-07-24 |