MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-02 for CUSTOM PACK NO. 000054 * 901241 manufactured by Professional Hospital Supply Inc.
[16310505]
Upon opening phs pack, a hair was seen inside the pack. The issue was identified prior to the patient coming into the operating room. New pack requested, set up continued.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4890946 |
| MDR Report Key | 4890946 |
| Date Received | 2015-07-02 |
| Date of Report | 2015-07-02 |
| Date of Event | 2015-06-25 |
| Report Date | 2015-07-02 |
| Date Reported to FDA | 2015-07-02 |
| Date Reported to Mfgr | 2015-07-06 |
| Date Added to Maude | 2015-07-06 |
| 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 | 3 |
| 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 | CUSTOM PACK NO. 000054 |
| Generic Name | KIT, SURGICAL INSTRUMENT, DISPOSABLE |
| Product Code | LRP |
| Date Received | 2015-07-02 |
| Model Number | * |
| Catalog Number | 901241 |
| Lot Number | 1184184 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | R |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PROFESSIONAL HOSPITAL SUPPLY INC |
| Manufacturer Address | 42500 WINCHESTER RD. TEMECULA CA 92590 US 92590 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-02 |