MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-13 for ABDOMINAL HYSTERECTOMY CUSTOM PACK DYNJ901467 manufactured by Medline.
[23684560]
Insect found on cuff of sterile gown in an abdominal hysterectomy custom pack.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5055613 |
| MDR Report Key | 5018974 |
| Date Received | 2015-08-13 |
| Date of Report | 2015-08-13 |
| Date of Event | 2015-08-12 |
| Date Added to Maude | 2015-08-20 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ABDOMINAL HYSTERECTOMY CUSTOM PACK |
| Generic Name | CUSTOM PACK |
| Product Code | LRP |
| Date Received | 2015-08-13 |
| Model Number | ABDOMINAL HYSTERECTOMY CUSTOM |
| Catalog Number | DYNJ901467 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-13 |