MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-09-18 for COMPERM 83040000 manufactured by Hartmann Usa.
[86452023]
The lot number of the product, patient age, weight, ethnicity/race or sex was not given by the customer. Hartmann usa has updated the product literature to state the product contains polyester. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[86452024]
The customer called to find out if comperm contained polyester or nylon. The customer used comperm on a patient with known allergies to nylon and polyester and the patient had an allergic reaction. The skin produced a rash.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1218946-2017-00001 |
| MDR Report Key | 6871872 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-09-18 |
| Date of Report | 2017-08-26 |
| Date of Event | 2017-08-11 |
| Date Mfgr Received | 2017-08-11 |
| Date Added to Maude | 2017-09-18 |
| 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 | OCCUPATIONAL THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR TREY THORSEN |
| Manufacturer Street | 481 LAKESHORE PARKWAY |
| Manufacturer City | ROCK HILL SC 29730 |
| Manufacturer Country | US |
| Manufacturer Postal | 29730 |
| Manufacturer Phone | 8039851161 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPERM |
| Generic Name | STOCKING, ELASTIC |
| Product Code | ILG |
| Date Received | 2017-09-18 |
| Catalog Number | 83040000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HARTMANN USA |
| Manufacturer Address | 481 LAKESHORE PARKWAY ROCK HILL SC 29730 US 29730 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-09-18 |