MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-20 for CUSTOM DYNJ PACKS N?A DYNJ54802A manufactured by Medline Industries, Inc..
[89835626]
Patient Sequence No: 1, Text Type: N, H10
[89835627]
The 18x18 lap sponge noted to be fraying. Fraying discovered by surgical tech before it was used on the patient and the sponge was removed from the field.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6964630 |
| MDR Report Key | 6964630 |
| Date Received | 2017-10-20 |
| Date of Report | 2017-10-13 |
| Date of Event | 2017-08-15 |
| Report Date | 2017-10-13 |
| Date Reported to FDA | 2017-10-13 |
| Date Reported to Mfgr | 2017-10-13 |
| Date Added to Maude | 2017-10-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | CUSTOM DYNJ PACKS |
| Generic Name | CUSTOM DYNJ PACKS |
| Product Code | OGD |
| Date Received | 2017-10-20 |
| Model Number | N?A |
| Catalog Number | DYNJ54802A |
| Lot Number | 17ED1252 |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-20 |