MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-14 for PEEL POUCH UTILITY BOWL 32 OUNCE STERILE 01232 manufactured by Medegen Medical Products Llc.
[72797400]
Patient Sequence No: 1, Text Type: N, H10
[72797401]
This facility recently changed to a new vendor for single-use peel pouch 32 ounce bowls. The bowls have a plastic pouch with a paper peel-away top (previous product had a plastic peel-away top). The staff is finding that the paper tops are easily damaged. So far, three bowls have had to be discarded because of damaged tops and one was found to have a slit opening in the paper top. Staff are concerned that they may not be seeing smaller defects which would affect sterility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6493073 |
| MDR Report Key | 6493073 |
| Date Received | 2017-04-14 |
| Date of Report | 2017-04-13 |
| Date of Event | 2017-04-06 |
| Report Date | 2017-04-12 |
| Date Reported to FDA | 2017-04-12 |
| Date Reported to Mfgr | 2017-04-12 |
| Date Added to Maude | 2017-04-14 |
| 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 | PEEL POUCH UTILITY BOWL 32 OUNCE STERILE |
| Generic Name | BASIN, STERILE |
| Product Code | FNY |
| Date Received | 2017-04-14 |
| Catalog Number | 01232 |
| Lot Number | 226894 |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDEGEN MEDICAL PRODUCTS LLC |
| Manufacturer Address | 209 MEDEGEN DR. GALLAWAY TN 38036 US 38036 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-14 |