MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1999-07-07 for SHIELED DISPOSABLE OBTURATOR, 5MM CO510 100550401 manufactured by Applied Medical Resources.
[126392]
An adverse event was reported. During a laparoscopic hernia procedure, it was reported that the dr placed an applied medical trocar into the pt's sub-pubic region and the trocar blade shields did not deploy, leaving the cutting blades exposed. The peritoneum was nicked by the trocar. An electro-cauterizing device was used to stop the bleeding. No further injury reporetd and no further action required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-1999-00015 |
| MDR Report Key | 230740 |
| Report Source | 07 |
| Date Received | 1999-07-07 |
| Date of Report | 1999-07-02 |
| Date of Event | 1999-06-08 |
| Date Mfgr Received | 1999-06-10 |
| Device Manufacturer Date | 1999-04-01 |
| Date Added to Maude | 1999-07-09 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SANDRA MEDLIN |
| Manufacturer Street | 26051 MERIT CIRCLE BUILDING 104 |
| Manufacturer City | LAGUNA HILLS CA 92653 |
| Manufacturer Country | US |
| Manufacturer Postal | 92653 |
| Manufacturer Phone | 9495826120 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHIELED DISPOSABLE OBTURATOR, 5MM |
| Generic Name | DISPOSABLE OBTURATOR |
| Product Code | FEC |
| Date Received | 1999-07-07 |
| Model Number | CO510 |
| Catalog Number | 100550401 |
| Lot Number | 99D448 |
| ID Number | * |
| Device Expiration Date | 2002-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 223722 |
| Manufacturer | APPLIED MEDICAL RESOURCES |
| Manufacturer Address | 26051 MERIT CIRCLE, BLDG 104 LAGUNA HILLS CA 92653 US |
| Baseline Brand Name | SHIELED DISPOSABLE OBTURATOR, 5MM |
| Baseline Generic Name | DISPOSABLE OBTURATOR |
| Baseline Model No | CO510 |
| Baseline Catalog No | 100550401 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1999-07-07 |