MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 1999-11-23 for ARGLY SPECIMEN TRAP 40CC CAPACITY 8884724500 manufactured by Kendall Healthcare Products Co.
[16482301]
The device was used during an exploratory laparotomy. Reportedly, the device broke and a component detached. The surgeon was unable to retrieve the component. The hosp has reported no pt injury occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610849-1999-00028 |
| MDR Report Key | 251987 |
| Report Source | 05,06,07 |
| Date Received | 1999-11-23 |
| Date of Report | 1999-10-25 |
| Date of Event | 1999-10-12 |
| Date Facility Aware | 1999-10-12 |
| Date Mfgr Received | 1999-10-25 |
| Date Added to Maude | 1999-12-02 |
| 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 | CINDY PROVENCHER |
| Manufacturer Street | 195 MCDERMOTT ROAD |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034926607 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARGLY SPECIMEN TRAP 40CC CAPACITY |
| Generic Name | SPECIMEN TRAP |
| Product Code | BYZ |
| Date Received | 1999-11-23 |
| Model Number | NA |
| Catalog Number | 8884724500 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 244045 |
| Manufacturer | KENDALL HEALTHCARE PRODUCTS CO |
| Manufacturer Address | 1855 A DORNOCH COURT TIJUANA SAN DIEGO CA 92173 US |
| Baseline Brand Name | ARGLY SPECIMEN TRAP 40CC CAPACITY |
| Baseline Generic Name | SPECIMEN TRAP |
| Baseline Model No | NA |
| Baseline Catalog No | 8884724500 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-11-23 |