MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-01-19 for NON28758 manufactured by Medline Industries, Inc..
[20356195]
Concern that a child swallowed a piece of elastic from a shoe cover.
Patient Sequence No: 1, Text Type: D, B5
[20420626]
A piece of elastic was found in the diaper of a child in the day care setting and thought to have come from the shoe covers used by parents and staff. No sample was returned for eval. No one witnessed the child with a piece of elastic in his/her mouth and no previous coughing or choking was observed. No photos were provided. We have not confirmed the shoe cover to be the source of the elastic piece found in the diaper. We have no trend for this issue. There was no injury to the child.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2013-00006 |
| MDR Report Key | 2929384 |
| Report Source | 06 |
| Date Received | 2013-01-19 |
| Date of Report | 2013-01-11 |
| Date of Event | 2012-12-31 |
| Date Mfgr Received | 2012-12-31 |
| Device Manufacturer Date | 2012-07-01 |
| Date Added to Maude | 2013-02-07 |
| 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 | 3 |
| Manufacturer Contact | JULIE FINLEY |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | SHOE COVER |
| Product Code | BWP |
| Date Received | 2013-01-19 |
| Catalog Number | NON28758 |
| Lot Number | 12GXFA0501 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | MUNDELEIN IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-01-19 |