MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-12-08 for ALLEN TRANSFER BOARD A-83001-A1 A-83001 manufactured by Allen Medical.
[14925178]
On (b)(6) 2009, allen received a copy of a voluntary medwatch report ((b)(4)) from the (b)(6) for an (b)(6) event. A patient received a four-inch long cut on their back as a result of their use of a transfer board with a broken end cap. The patient was treated for the wound. There were no permanent disabilities or long-term injuries requiring treatment.
Patient Sequence No: 1, Text Type: D, B5
[15293050]
Allen contacted the reporter, (b)(6) risk manager (b)(6), to investigate. She provided the name and number for (b)(6) of safe patient handling at the va to determine if the damaged end cap would be made available or if they could be photographed. (b)(6) said that following the incident, eight transfer boards with broken end caps were taken out of use and the caps replaced. They have since been returned to service, he said. A return sales order with a shipping label was issued to (b)(6) so that the end caps could be returned for evaluation, but the components were never received by allen.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221538-2009-00013 |
| MDR Report Key | 2577048 |
| Report Source | 06 |
| Date Received | 2009-12-08 |
| Date of Report | 2009-11-09 |
| Date of Event | 2009-10-20 |
| Date Mfgr Received | 2009-11-09 |
| Date Added to Maude | 2012-05-21 |
| 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 | NANCY ROYALTY, DIRECTOR |
| Manufacturer Street | ONE POST OFFICE SQUARE |
| Manufacturer City | ACTON MA 01720 |
| Manufacturer Country | US |
| Manufacturer Postal | 01720 |
| Manufacturer Phone | 8885214277 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALLEN TRANSFER BOARD |
| Generic Name | TRANFER BOARD |
| Product Code | FMR |
| Date Received | 2009-12-08 |
| Model Number | A-83001-A1 |
| Catalog Number | A-83001 |
| Lot Number | NA |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLEN MEDICAL |
| Manufacturer Address | ACTON MA 01720 US 01720 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-08 |