MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2012-07-20 for PINPOINT I-115 manufactured by Beekley Corporation.
[20333136]
Three hospitals in (b)(6) had the product fall off the pt overnight. It had been applied in the evening, and was to be worn overnight for use in the morning, but a few of them had fallen off.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9021987-2012-00011 |
| MDR Report Key | 2679525 |
| Report Source | 08 |
| Date Received | 2012-07-20 |
| Date of Report | 2012-07-16 |
| Date of Event | 2012-05-14 |
| Date Added to Maude | 2012-11-13 |
| 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 | AYN LAPLANT, CEO |
| Manufacturer Street | ONE PRESTIGE LANE |
| Manufacturer City | BRISTOL CT 06010 |
| Manufacturer Country | US |
| Manufacturer Postal | 06010 |
| Manufacturer Phone | 8605834700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PINPOINT |
| Generic Name | SYSTEM, X-RAY, FILM MARKING, RADIOGRAPHIC |
| Product Code | JAC |
| Date Received | 2012-07-20 |
| Catalog Number | I-115 |
| Lot 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 | BEEKLEY CORPORATION |
| Manufacturer Address | BRISTOL CT 06010 US 06010 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-07-20 |