MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-24 for CMC LAPAROTOMY - LF CUSTOM STERILE SURGICAL SUPPLY PACK CDLP15B-01 manufactured by American Contract Systems.
[83668493]
Patient Sequence No: 1, Text Type: N, H10
[83668494]
Raytec sponge in sterile laparotomy, lf custom surgical pack is noted to be frayed upon opening. Also, when not visually frayed upon opening, the raytec sponge frays easily upon use. This has the potential for retained fibers from surgical sponge, which can contribute to post-operative infection, increased granuloma formation, etc.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6816704 |
| MDR Report Key | 6816704 |
| Date Received | 2017-08-24 |
| Date of Report | 2017-07-14 |
| Date of Event | 2017-06-22 |
| Report Date | 2017-06-22 |
| Date Reported to FDA | 2017-06-22 |
| Date Reported to Mfgr | 2017-06-22 |
| Date Added to Maude | 2017-08-24 |
| 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 | CMC LAPAROTOMY - LF CUSTOM STERILE SURGICAL SUPPLY PACK |
| Generic Name | TRAY, SURGICAL |
| Product Code | LRP |
| Date Received | 2017-08-24 |
| Model Number | CDLP15B-01 |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN CONTRACT SYSTEMS |
| Manufacturer Address | 4801 WEST 81ST STREET BLOOMINGTON MN 55437 US 55437 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-24 |