MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-07 for LAP CHOLE PACK DYNJ0395986K manufactured by Medline Industries, Inc..
[101771488]
Patient Sequence No: 1, Text Type: N, H10
[101771489]
A custom medline surgical pack was received with a note stating "the outer dust cover had a tear in it and there was also a tear on the blue drape cover-exactly in the same spot as the outer dust cover hole. " the holes had been circled by surgical staff, and were photographed. This was discovered prior to the start of a case, and no harm came to the patient. The field rep has been made aware and will pick up the pack to pass along to medline's quality team.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7319978 |
| MDR Report Key | 7319978 |
| Date Received | 2018-03-07 |
| Date of Report | 2018-03-02 |
| Date of Event | 2018-02-02 |
| Report Date | 2018-03-02 |
| Date Reported to FDA | 2018-03-02 |
| Date Reported to Mfgr | 2018-03-02 |
| Date Added to Maude | 2018-03-07 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LAP CHOLE PACK |
| Generic Name | LAPAROSCOPY KIT |
| Product Code | FDE |
| Date Received | 2018-03-07 |
| Model Number | DYNJ0395986K |
| Catalog Number | DYNJ0395986K |
| Lot Number | 17ID3137 |
| Device Availability | Y |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | 3 LAKES DR NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-07 |