MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-02-26 for BIOGEL PI MICRO 48575 manufactured by Molnlycke.
[137158431]
A hospital staff member experienced an anaphylactic reaction associated with wear of surgical gloves. Upon donning, they experienced itching. Upon removal, they experienced swollen lips, hands and arms with localized red rash with burning sensation resulting in emergency treatment of antihistamines. They were released and placed on medical leave. The issue has since resolved and the staff member has returned to work.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004763499-2019-00002 |
| MDR Report Key | 8370350 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-02-26 |
| Date of Report | 2019-01-28 |
| Date of Event | 2019-01-16 |
| Date Mfgr Received | 2019-01-28 |
| Device Manufacturer Date | 2018-09-21 |
| Date Added to Maude | 2019-02-26 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS PAT STRAHL |
| Manufacturer Street | 5550 PEACHTREE PARKWAY SUITE 500 |
| Manufacturer City | NORCROSS GA 30092 |
| Manufacturer Country | US |
| Manufacturer Postal | 30092 |
| Manufacturer Phone | 4042700985 |
| Manufacturer G1 | MOLNLYCKE HEALTHCARE |
| Manufacturer Street | 5550 PEACHTREE PARKWAY 500 |
| Manufacturer City | NORCROSS GA 30092 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30092 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOGEL PI MICRO |
| Generic Name | SURGEONS GLOVES |
| Product Code | KGO |
| Date Received | 2019-02-26 |
| Model Number | 48575 |
| Lot Number | 181192 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MOLNLYCKE |
| Manufacturer Address | 5550 PEACHTREE PARKWAY SUITE 500 NORCROSS GA 30092 US 30092 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-26 |