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 2019-05-16 for BIOGEL PI MICRO 48570 manufactured by Molnlycke.
[145619908]
A report was received that the user found a hole in the glove after a surgical procedure. No patient or user harm reported. Follow up information was requested and received on 17apr2019 which indicated a fragment of the glove was recognized by the surgeon as missing when glove was removed and the missing piece was not located. No patient or user impact reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004763499-2019-00006 |
| MDR Report Key | 8617985 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-05-16 |
| Date of Report | 2019-04-11 |
| Date of Event | 2019-04-09 |
| Date Mfgr Received | 2019-04-17 |
| Date Added to Maude | 2019-05-16 |
| 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 | MS PAT STRAHL |
| Manufacturer Street | 5550 PEACHTREE PARKWAY SUITE 500 |
| Manufacturer City | NORCROSS GA 30092 |
| Manufacturer Country | US |
| Manufacturer Postal | 30092 |
| Manufacturer Phone | 4703750171 |
| Manufacturer G1 | MOLNLYCKE |
| Manufacturer Street | 5550 PEACHTREE PARKWAY SUITE 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 | 2019-05-16 |
| Model Number | 48570 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-05-16 |