MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-02-13 for 3M? IOBAN? 2 ANTIMICROBIAL INCISE DRAPE N/A 6648 manufactured by 3m Health Care.
[136027572]
Patient identifier, weight: information was not provided. Lot #, device manufacture date: without a lot number, the expiration date and manufacture date could not be determined. Occupation: occupation of reporter was not provided. The customer did not provide information related to the product application and removal technique. The product instructions for use (ifu) states the drape should be applied without tension. The ifu also states the drape should be removed by gently peeling it back at a 180-degree angle from the skin. The ifu includes the notation that the skin of elderly patients is typically fragile and thus requires even greater care when applying and removing adhesive products such as drapes.
Patient Sequence No: 1, Text Type: N, H10
[136027573]
A hospital employee in (b)(6) reported 6648 3m? Ioban? 2 antimicrobial incise drapes were applied to a patient for cardiac surgery. The drapes were reportedly applied to intact skin. Alcoholic chlorhexidine was used for skin preparation. A circular skin injury in the thoracic/left breast area reportedly occurred when the drape was removed. (b)(6) gauze and a gauze dressing were applied to the site and secured with tape. Dermazine (sulfadiazine silver) was also reportedly used for treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2019-00028 |
| MDR Report Key | 8335697 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-02-13 |
| Date of Report | 2019-02-13 |
| Date of Event | 2019-01-06 |
| Date Mfgr Received | 2019-01-15 |
| Date Added to Maude | 2019-02-13 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | DIANNE GIBBS |
| Manufacturer Street | 2510 CONWAY AVE 3M CENTER BUILDING 275-5W-06 |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517379117 |
| Manufacturer G1 | 3M COMPANY BROOKINGS |
| Manufacturer Street | 601 22ND AVE SOUTH |
| Manufacturer City | BROOKINGS SD 57006 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 57006 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M? IOBAN? 2 ANTIMICROBIAL INCISE DRAPE |
| Generic Name | IOBAN INCISE DRAPE |
| Product Code | KKX |
| Date Received | 2019-02-13 |
| Model Number | N/A |
| Catalog Number | 6648 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | 2510 CONWAY AVE ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2019-02-13 |