MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2005-10-11 for HEELBO L-BOW ARM HOLDER 12077 manufactured by Hollister, Inc..
[433954]
Patient underwent an eye surgery and an elbow arm restraint was placed by hospital staff on the patient's elbows to keep the patient from scratching an irritable post-op wound. During the course of recovery the pt scratched an eye cornea. It was further reported the eye became infected. Product was not discontinued, instead a sock was placed over the arm holder to minimize further potential scratching.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1921454-2005-00001 |
| MDR Report Key | 640769 |
| Report Source | 00 |
| Date Received | 2005-10-11 |
| Date of Report | 2005-09-19 |
| Date Mfgr Received | 2005-09-19 |
| Date Added to Maude | 2005-10-17 |
| 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 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 2000 HOILISTER DR |
| Manufacturer City | LIBERTYVILLE IL 60048 |
| Manufacturer Country | US |
| Manufacturer Postal | 60048 |
| Manufacturer Phone | 8746802849 |
| Manufacturer G1 | HOLLISTER INC. |
| Manufacturer Street | SCHNIEDER DR |
| Manufacturer City | KIRKSVILLE MO 63501088 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63501 0888 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEELBO L-BOW ARM HOLDER |
| Generic Name | ARM HOLDER |
| Product Code | ILI |
| Date Received | 2005-10-11 |
| Model Number | NA |
| Catalog Number | 12077 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 630277 |
| Manufacturer | HOLLISTER, INC. |
| Manufacturer Address | 200 HOLLISTER DRIVE LIBERTYVILLE IL 60048 US |
| Baseline Brand Name | HEELBO L-BOW ARM HOLDER |
| Baseline Generic Name | ARM HOLDER |
| Baseline Model No | NA |
| Baseline Catalog No | 12077 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-10-11 |