MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-09-29 for LAPAROTOMY SPONGES UNKNOWN manufactured by Medical Action Industries.
[14536]
Law suit alleges lap sponges used during surgery were non-sterile and were approximate cause or a contributing cause of injuries sustained by the plaintiff. Co cannot determine whether or not product involved in this report caused or contributed to this alleged reported incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1483039-1995-00007 |
| MDR Report Key | 27120 |
| Date Received | 1995-09-29 |
| Date of Report | 1995-09-28 |
| Date of Event | 1993-09-14 |
| Date Facility Aware | 1995-09-21 |
| Report Date | 1995-09-28 |
| Date Reported to FDA | 1995-09-29 |
| Date Reported to Mfgr | 1995-09-29 |
| Date Added to Maude | 1995-10-18 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | ATTORNEY |
| 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 | LAPAROTOMY SPONGES |
| Generic Name | LAPAROTOMY SPONGES |
| Product Code | GER |
| Date Received | 1995-09-29 |
| Model Number | NA |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 27959 |
| Manufacturer | MEDICAL ACTION INDUSTRIES |
| Manufacturer Address | 150 MOTOR PARKWAY HAUPPAUGE NY 11788 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-09-29 |