MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-03-10 for 3M COBAN SELF ADHERENT WRAP UNK manufactured by 3m Health Care.
[69635997]
(b)(4). Customer reported a coban wrap was applied to her arm following a blood draw in an er. Customer did not have product catalog number or lot number. Customer reported she had a known latex allergy. The 3m medical complaint investigator attempted to identify the product that was applied. Based on the investigation, the facility appeared to have both 3m? Coban? Wrap and 3m? Coban? Lf wrap available for ordering. The 3m coban self adherent wrap contains the following information on the instructions for use (ifu): caution this product contains natural rubber latex which may cause allergic reactions. The ifu also contains a symbol noting the following explanation: explanation of symbols caution: this product contains natural rubber latex which may cause allergic reactions.
Patient Sequence No: 1, Text Type: N, H10
[69635998]
Customer reported she was seen in a hospital emergency room (er) due to a rash that had intensified. While in the er, she reportedly had a coban wrap (unknown catalog number) applied to secure a cotton ball following a blood draw. Customer allegedly experienced a severe reaction described as 2nd degree latex burns on skin exposed to the area where the product had been applied. She reported the area became infected, painful and she was seen in the er. She reportedly received iv medication while in the er and received a rx for silver sulfadiazine cream. She reportedly had two subsequent anaphylactic reactions that reportedly may have been triggered by multiple factors including: combination of latex allergy dermal burns, allergy to prescriptions, food allergies, and dehydration. Customer reported she has a known latex allergy and multiple food allergies. Customer reported the burns have now healed following two solid weeks of treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2017-00028 |
| MDR Report Key | 6396605 |
| Report Source | CONSUMER |
| Date Received | 2017-03-10 |
| Date of Report | 2017-02-28 |
| Date of Event | 2016-12-08 |
| Date Mfgr Received | 2017-02-28 |
| Date Added to Maude | 2017-03-10 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KAREN KRENIK |
| Manufacturer Street | 3M CENTER BUILDING 275-5W-06 |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517333091 |
| 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 COBAN SELF ADHERENT WRAP |
| Generic Name | COBAN WRAP |
| Product Code | FQM |
| Date Received | 2017-03-10 |
| Catalog 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. Life Threatening; 2. Required No Informationntervention | 2017-03-10 |