MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-10-21 for MEDLINE LAP CHOLE I STERILE PACK DYNJS0310 * manufactured by Medline.
[2343967]
Medline's lap chole i sterile pack had only 9 out of 10 gauze 4x4 16 ply xray opaque (10cm x 10cm). No patient details were given. Mis-count was made prior to surgery. Mis-count could have lead to additional xrays to find the sponge. This was a near miss. ======================manufacturer response for lap chole i sterile pack, medline lap chole i sterile pack (per site reporter). ======================rep will review.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2318143 |
| MDR Report Key | 2318143 |
| Date Received | 2011-10-21 |
| Date of Report | 2011-10-21 |
| Date of Event | 2011-10-19 |
| Report Date | 2011-10-21 |
| Date Reported to FDA | 2011-10-21 |
| Date Added to Maude | 2011-11-01 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | MEDLINE LAP CHOLE I STERILE PACK |
| Generic Name | LAP CHOLE I STERILE PACK |
| Product Code | GER |
| Date Received | 2011-10-21 |
| Returned To Mfg | 2011-10-21 |
| Model Number | DYNJS0310 |
| Catalog Number | * |
| Lot Number | 11DS0001 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE |
| Manufacturer Address | ONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-21 |