MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-31 for SURGINEEDLE 172016 UNKNOWN manufactured by U.s. Surgical Corp..
[13764]
On 11/23/94, one of our pts underwent a laparoscopic surgical procedure. The pt was released from facility without apparent incident. On 1/11/95, continuous quality improvement committee received a report from the surgeon relating the following event. On 12/10/94, the pt had to have the outer sheath of a needle removed from the buttock area. The sheath had apparently become detached, and had worked its way from the pt's abdomen, to the buttock area. Needle was apparently received defective from the mfr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 20472 |
| MDR Report Key | 20472 |
| Date Received | 1995-01-31 |
| Date of Report | 1995-01-30 |
| Date of Event | 1994-11-23 |
| Date Facility Aware | 1995-01-26 |
| Report Date | 1995-01-30 |
| Date Reported to FDA | 1995-01-30 |
| Date Reported to Mfgr | 1995-01-30 |
| Date Added to Maude | 1995-03-22 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURGINEEDLE |
| Generic Name | PNEUMOPERITONEUM NEEDLE |
| Product Code | FHP |
| Date Received | 1995-01-31 |
| Model Number | 172016 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 20359 |
| Manufacturer | U.S. SURGICAL CORP. |
| Manufacturer Address | NORWALK CT 06856 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1995-01-31 |