MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-03-29 for SHEA FOAM HEAD SUPPORT 150180 manufactured by Gyrus Ent Llc.
[1436205]
The customer discovered a razor blade in the package. It was with the device inside the shrink wrap. Discovered prior to removing the shrink wrap and using the device. No injury involved, but there was a potential for injury.
Patient Sequence No: 1, Text Type: D, B5
[8540088]
Customer returned the device unopened. The razor blade in the package was likely accidentally trapped inside the plastic as the foam was pulled along the work table. The dhr was reviewed and there are no issues with the record. The lot is no longer on hand. No other reports for the lot. No other similar reports for the head supports. Appears to be an isolated event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1037007-2010-00003 |
| MDR Report Key | 1649777 |
| Report Source | 06 |
| Date Received | 2010-03-29 |
| Date of Report | 2010-03-29 |
| Date of Event | 2010-03-18 |
| Date Mfgr Received | 2010-03-18 |
| Device Manufacturer Date | 2010-01-01 |
| Date Added to Maude | 2011-04-28 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. DOLAN MILLS |
| Manufacturer Street | 2925 APPLING ROAD |
| Manufacturer City | BARTLETT TN 38133 |
| Manufacturer Country | US |
| Manufacturer Postal | 38133 |
| Manufacturer Phone | 9013730200 |
| Manufacturer G1 | GYRUS ENT LLC |
| Manufacturer Street | 2925 APPLING ROAD |
| Manufacturer City | BARTLETT TN 38133 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38133 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHEA FOAM HEAD SUPPORT |
| Product Code | EPW |
| Date Received | 2010-03-29 |
| Returned To Mfg | 2010-03-23 |
| Catalog Number | 150180 |
| Lot Number | IH145646 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ENT LLC |
| Manufacturer Address | BARTLETT TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-03-29 |