MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2012-06-20 for MINI SHEET 00-8600-059-00 manufactured by Zimmer Surgical.
[2730298]
It was reported that the zimmer ultracare wound sheet is holding in moisture and causing skin irritation. Additional clinical follow up indicated that the sheeting was reported to have been used for a premature infant that was in a thermostatically controlled (35-37 degree celsius) environment. After "a brief period" the customer noted the infant's skin to be red and peeling. An ointment was applied to treat the skin. Additional clinical follow up with the hospital indicated that the use of wound sheeting has been routine in the nicu (neonatal intensive care unit) at the facility since at least 2000. The customer was unable to provide info regarding why the product was chosen. No other info regarding the reason for use of wound sheeting was provided.
Patient Sequence No: 1, Text Type: D, B5
[10063047]
The product was not returned for eval. There was indication of lot number, therefore the device history record could not be reviewed. Unable to determine cause of complaint.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1035617-2012-00004 |
| MDR Report Key | 2631136 |
| Report Source | 01,05,08 |
| Date Received | 2012-06-20 |
| Date of Report | 2012-05-25 |
| Date of Event | 2012-05-01 |
| Date Mfgr Received | 2012-05-25 |
| Date Added to Maude | 2012-06-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CINDY DICKEY |
| Manufacturer Street | 1872 OLD MOUNTAIN RD |
| Manufacturer City | STATESVILLE NC 28625 |
| Manufacturer Country | US |
| Manufacturer Postal | 28625 |
| Manufacturer Phone | 7048731001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MINI SHEET |
| Generic Name | MINI SHEET |
| Product Code | FPY |
| Date Received | 2012-06-20 |
| Model Number | NA |
| Catalog Number | 00-8600-059-00 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER SURGICAL |
| Manufacturer Address | 1872 OLD MOUNTAIN RD STATESVILLE NC 28625 US 28625 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-06-20 |